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Tests Waived by FDA from January 2000 to Present

CLIA WAIVED STATUS Revised 12/22/1999

Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a test system name, you can view the CLIA data for that test system, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of categorization of the test, then by test system name. This list does not include test systems that were characterized by the CDC prior to January 2000.

Document Test System Name
Analyte		 Analyte Specialty Effective Date
  AMERITEK DBEST URINARY TRACT INFECTION TEST KIT  
K990873 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 01/03/2002
  CONSUMER CHOICE SYSTEMS URINARY TRACT INFECTION TEST STRIP  
K990873 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 01/03/2002
  VICTORCH HCG STRIP  
K013702 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 01/03/2002
  VICTORCH HCG TEST CARD  
K013678 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 01/03/2002
  POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS PROFESSIONAL AND OTC  
K014099 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/21/2001
  ACON STREP A RAPID TEST STRIP  
K010582 STREPTOCOCCUS, GROUP A Bacteriology 12/18/2001
  BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON DS STREP A  
K010582 STREPTOCOCCUS, GROUP A Bacteriology 12/18/2001
  CAMBRIDGE DIAGNOSTICS INVERNESS MEDICAL EARLY PREGNANCY TEST  
K013907 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/18/2001
  APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K011233 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  CHAY MEDICAL EXCELSIOR TEST STRIPS  
K013342 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  HOME DIAGNOSTICS LIFE MEDICAL BLOOD GLUCOSE SYSTEM  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  HOME DIAGNOSTICS LONGS BLOOD GLUCOSE SYSTEM  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  HOME DIAGNOSTICS MEIJER BLOOD GLUCOSE SYSTEM  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  HYPOGUARD ASSURE II BLOOD GLUCOSE SYSTEM  
K002621 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  HYPOGUARD ASSURE II BLOOD GLUCOSE SYSTEM  
K011233 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  LIFESCAN FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K011479 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K011479 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM  
K012975 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9064)  
K013410 AMPHETAMINES Toxicology / TDM 12/17/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9069)  
K013412 METHAMPHETAMINES Toxicology / TDM 12/17/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9074)  
K013409 COCAINE METABOLITES Toxicology / TDM 12/17/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9079)  
K013408 CANNABINOIDS (THC) Toxicology / TDM 12/17/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9084)  
K013407 OPIATES Toxicology / TDM 12/17/2001
  POLYMER TECHNOLOGY SYSTEMS BIOSCANNER  
K013068 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  QUIDEL QUICKVUE URINCHEK 10+SG  
K861255 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 12/17/2001
  QUIDEL QUICKVUE URINCHEK 10+SG  
K861255 URINE QUALITATIVE DIPSTICK ASCORBIC ACID Urinalysis 12/17/2001
  QUIDEL QUICKVUE+ INFECTIOUS MONONUCLEOSIS  (WHOLE BLOOD)
K902510 INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO) General Immunology 12/17/2001
  REMEL RIM A.R.C. HCG COMBO PREGNANCY TEST  
K932635 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/17/2001
  ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K012324 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/17/2001
  TCI OVULATION TESTER  
K013323 FERN TEST, SALIVA Endocrinology 12/05/2001
  JANT PHARMACAL ACCUSTRIP HCG PREGNANCY TEST  
K954444 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/04/2001
  QUIDEL QUICKVUE URINCHEK 2+  
K861255 URINE QUALITATIVE DIPSTICK GLUCOSE Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 2+  
K861255 URINE QUALITATIVE DIPSTICK PROTEIN Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 2+  
K861255 URINE QUALITATIVE DIPSTICK ASCORBIC ACID Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 6+  
K861255 URINE QUALITATIVE DIPSTICK GLUCOSE Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 6+  
K861255 URINE QUALITATIVE DIPSTICK BLOOD Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 6+  
K861255 URINE QUALITATIVE DIPSTICK PH Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 6+  
K861255 URINE QUALITATIVE DIPSTICK PROTEIN Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 6+  
K861255 URINE QUALITATIVE DIPSTICK LEUKOCYTES Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 6+  
K861255 URINE QUALITATIVE DIPSTICK ASCORBIC ACID Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK GLUCOSE Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK KETONE Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK BLOOD Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK PH Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK PROTEIN Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK UROBILINOGEN Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK NITRITE Urinalysis 12/04/2001
  QUIDEL QUICKVUE URINCHEK 8+  
K861255 URINE QUALITATIVE DIPSTICK ASCORBIC ACID Urinalysis 12/04/2001
  HOME DIAGNOSTICS AMERICAN FARE BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/19/2001
  HOME DIAGNOSTICS FAMILY PHARMACY BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/19/2001
  HOME DIAGNOSTICS HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/19/2001
  HOME DIAGNOSTICS HEB INCONTROL BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/19/2001
  HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/19/2001
  HOME DIAGNOSTICS PATHMARK BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/19/2001
  POLYMER TECHNOLOGY SYSTEMS BIOSCANNER BEYOND  
K013203 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/13/2001
  PROVALIS DIAGNOSTICS GLYCOSAL II HBA1C  
K011933 GLYCOSYLATED HEMOGLOBIN (HGB A1C) General Chemistry 11/09/2001
  BAYER GLUCOMETER DEX 2  
K963500 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/07/2001
  BIOCARE CORP. URIMATE REAGENT STRIP FOR URINALYSIS  
K012829 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 11/06/2001
  HOME DIAGNOSTICS HOMEBEST BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/06/2001
  HOME DIAGNOSTICS LEADER BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/06/2001
  HOME DIAGNOSTICS MEDIC DIRECT BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/06/2001
  HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM - IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/06/2001
  UNIPATH CLEARBLUE EASY EARLY RESULT PREGNANCY TEST  
K013372 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 11/06/2001
  BION DIAGNOSTIC SCIENCES POLY STAT HCG TEST  
K012559 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 10/15/2001
  BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST DEVICE  
K013194 HCG, URINE Endocrinology 10/15/2001
  BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST STRIP  
K013194 HCG, URINE Endocrinology 10/15/2001
  FEMTEK PHEM-ALERT  
K012230 VAGINAL PH General Chemistry 10/09/2001
  BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT SENSA  
K880499 FECAL OCCULT BLOOD General Chemistry 10/05/2001
  ABCO OCCULT BLOOD-E.S. (EXTRA SENSITIVE)  
K003359 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  BERGEN BRUNSWIG FECAL OCCULT BLOOD-E.S. (EXTRA SENSITIVE)  
K003359 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  BERGEN BRUNSWIG TEST FOR FECAL OCCULT BLOOD  
K911075 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  CIDA COLOCHECK  
K911075 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  CIDA COLOCHECK-E.S. (EXTRA SENSITIVE)  
K003359 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  FISHER HEALTHCARE SURE-VUE FECAL OCCULT BLOOD  
K911075 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  FISHER HEALTHCARE SUREVUE FECAL OCCULT BLOOD-E.S. (EXTRA-SENSITIVE)  
K003359 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  PSS SELECT OCCULT BLOOD TEST  
K911075 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  PSS SELECT OCCULT BLOOD TEST-E.S. (EXTRA SENSITIVE)  
K003359 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  STANBIO HEMA-SCREEN  
K911075 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  STARLINE COLOSCAN  
K911075 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  STARLINE COLOSCAN-E.S. (EXTRA SENSITIVE)  
K003359 FECAL OCCULT BLOOD General Chemistry 09/27/2001
  BAYER GLUCOMETER DEX TEST SENSOR  
K012205 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/31/2001
  HOME DIAGNOSTICS GAMBRO BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/31/2001
  HOME DIAGNOSTICS WALGREENS BLOOD GLUCOSE SYSTEM  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/31/2001
  BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT  
K821884 GASTRIC OCCULT BLOOD General Chemistry 08/30/2001
  BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT  
K821884 GASTRIC PH General Chemistry 08/30/2001
  MEDICAL INSTRUMENTS PRONTO DRY  
K002451 HELICOBACTER PYLORI Bacteriology 08/30/2001
  ACON QUIK-CHECK OVULATION PREDICTOR TEST  
K012252 OVULATION TEST (LH) BY VISUAL COLOR COMPARISON Endocrinology 08/29/2001
  DIAGNOSTIC CHEMICALS IMMUNODIP URINARY ALBUMIN SCREEN  
K994035 MICROALBUMIN General Chemistry 08/29/2001
  MIZUHO USA ABSOLUTE II PREGNANCY TEST  
K000844 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 08/29/2001
  W.H.P.M. WH ACCU TEST PREGNANCY TEST  
K012284 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 08/29/2001
  CHEMBIO HCG STAT PAK II  
K011550 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 08/28/2001
  HYPOGUARD QUICKTEK BLOOD GLUCOSE METER  
K010039 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/28/2001
  ACON QUIK-CHECK HOME PREGNANCY TEST  
K012215 HCG, URINE Endocrinology 08/23/2001
  ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 CANNABINOIDS (THC) Toxicology / TDM 08/23/2001
  ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 COCAINE METABOLITES Toxicology / TDM 08/23/2001
  ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER OTC  
K012210 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/23/2001
  SA SCIENTIFIC SURE-VUE URINE HCG  
K010522 HCG, URINE Endocrinology 08/23/2001
  METRIKA A1C NOW  
K000887 GLYCOSYLATED HEMOGLOBIN (HGB A1C) General Chemistry 08/17/2001
  EMBRYOTECH LABORATORIES FERTILMARQ HOME DIAGNOSTIC SCREENING TEST FOR MALE INFERTILITY  
K011679 SEMEN Hematology 08/15/2001
  LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (PROFESSIONAL USE)
K001699 PROTHROMBIN TIME (PT) Hematology 08/06/2001
  LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (PRESCRIPTION HOME USE)
K001699 PROTHROMBIN TIME (PT) Hematology 08/06/2001
  BRITE-LIFE BLOOD GLUCOSE SYSTEM IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/03/2001
  CVS / PHARMACY BLOOD GLUCOSE SYSTEM IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/03/2001
  GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/03/2001
  SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM IQ  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/03/2001
  OSTEX INTERNATIONAL OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE  
K011052 COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) Endocrinology 07/30/2001
  KDK CORPORATION LACTATE PRO SYSTEM  (FOR OTC USE)
K980908 LACTIC ACID (LACTATE) General Chemistry 07/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9078T)  
K010654 CANNABINOIDS (THC) Toxicology / TDM 07/27/2001
  SA SCIENTIFIC SURE VUE SERUM/URINE HCG  
K010593 HCG, URINE Endocrinology 07/27/2001
  QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097 STREPTOCOCCUS, GROUP A Bacteriology 07/26/2001
  ITC PROTIME MICROCOAGULATION SYSTEM  (PRESCRIPTION HOME USE)
K010599 PROTHROMBIN TIME (PT) Hematology 07/23/2001
  ITC PROTIME MICROCOAGULATION SYSTEM  (PROFESSIONAL USE)
K010599 PROTHROMBIN TIME (PT) Hematology 07/23/2001
  CHEMBIO SURE CHECK OVULATION PREDICTOR  
K010244 LUTEINIZING HORMONE (LH) Endocrinology 07/20/2001
  HOME DIAGNOSTICS MEDICINE SHOPPE BLOOD GLUCOSE SYSTEM  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/20/2001
  IVERNESS MEDICAL TECHNOLOGY INDUO BLOOD GLUCOSE METER  
K011616 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/20/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9068T)  
K010653 METHAMPHETAMINES Toxicology / TDM 07/20/2001
  ICON DS STREP A  
K010582 STREPTOCOCCUS, GROUP A Bacteriology 07/17/2001
  FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT  
K002253 CANNABINOIDS (THC) Toxicology / TDM 07/10/2001
  FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT  
K002253 COCAINE METABOLITES Toxicology / TDM 07/10/2001
  ADVANTAGE DIAGNOSTICS ADVANTAGE THC (MARIJUANA) HOME DRUG TEST  
K010921 CANNABINOIDS (THC) Toxicology / TDM 07/03/2001
  HOME DIAGNOSTICS APICAL BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/03/2001
  HOME DIAGNOSTICS BROOKS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/03/2001
  HOME DIAGNOSTICS DIABETIC.COM BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/03/2001
  HOME DIAGNOSTICS EPIC PHARMACIES BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/03/2001
  HOME DIAGNOSTICS FARMACIAS EL AMAL BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/03/2001
  HOME DIAGNOSTICS MEDPLUS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/03/2001
  SA SCIENTIFIC SURE-VUE SERUM/URINE HCG-STAT  
K990684 HCG, URINE Endocrinology 07/03/2001
  WAMPOLE PREVUE B. BURGDORFERI  
K981913 LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS) General Immunology 06/19/2001
  BIOMEDICAL PRODUCTS DOUBLE-CHEK STRIP URINALYSIS  
K993850 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 06/12/2001
  SA SCIENTIFIC SAS ULTRA HCG SERUM/URINE  
K990684 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 06/04/2001
  GENZYME SIGNIFY HCG URINE/SERUM TEST  
K964155 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 05/02/2001
  BAYER MULTISTIX PRO 10LS REAGENT STRIPS  
K992257 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 05/01/2001
  BAYER MULTISTIX PRO 10LS REAGENT STRIPS  
K992257 URINE QUALITATIVE DIPSTICK CREATININE Urinalysis 05/01/2001
  BAYER MULTISTIX PRO 11 REAGENT STRIPS  
K992257 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 05/01/2001
  BAYER MULTISTIX PRO 11 REAGENT STRIPS  
K992257 URINE QUALITATIVE DIPSTICK CREATININE Urinalysis 05/01/2001
  BAYER MULTISTIX PRO 7G REAGENT STRIPS  
K992257 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 05/01/2001
  BAYER MULTISTIX PRO 7G REAGENT STRIPS  
K992257 URINE QUALITATIVE DIPSTICK CREATININE Urinalysis 05/01/2001
  BECKMAN COULTER PRIMARY CARE DIAGNOSTICS FLEXSURE HP TEST  (WHOLE BLOOD)
K960183 HELICOBACTER PYLORI ANTIBODIES General Immunology 05/01/2001
  TECO DIAGNOSTICS URS-1K URINE REAGENT STRIPS  (OVER-THE-COUNTER)
K003987 KETONE, URINE General Chemistry 04/30/2001
  BECKMAN COULTER ICON DS HCG TEST STRIP  (URINE)
K993203 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 04/23/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9063 T)  
K010645 AMPHETAMINES Toxicology / TDM 04/23/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9073 T)  
K010650 COCAINE METABOLITES Toxicology / TDM 04/23/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9083 T)  
K010646 OPIATES Toxicology / TDM 04/23/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9133 T)  
K010651 PHENCYCLIDINE (PCP) Toxicology / TDM 04/23/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 AMPHETAMINES Toxicology / TDM 04/04/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 CANNABINOIDS (THC) Toxicology / TDM 04/04/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 COCAINE METABOLITES Toxicology / TDM 04/04/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 METHAMPHETAMINE/AMPHETAMINE Toxicology / TDM 04/04/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 OPIATES Toxicology / TDM 04/04/2001
  CYGNUS, INC. GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER  
P990026 GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE) General Chemistry 03/28/2001
  HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM  
K010403 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 03/27/2001
  ROCHE DIAGNOSTICS ACCU-CHEK ADVANTAGE {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP} 
K010362 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 03/27/2001
  ROCHE DIAGNOSTICS ACCU-CHEK COMPLETE SYSTEM {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP} 
K010362 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 03/27/2001
  BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON FX STREP A IMMUNOCHEMICAL STREP A ANTIGEN TEST  
K960712 STREPTOCOCCUS, GROUP A Bacteriology 03/16/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9068)  
K003858 METHAMPHETAMINES Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 AMPHETAMINES Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 CANNABINOIDS (THC) Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 COCAINE METABOLITES Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 METHAMPHETAMINES Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 OPIATES Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 CANNABINOIDS (THC) Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 METHAMPHETAMINES Toxicology / TDM 02/27/2001
  PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 OPIATES Toxicology / TDM 02/27/2001
  BIOMERICA EZ-HCG URINE (PREGNANCY TEST)  
K003856 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 02/26/2001
  HOME DIAGNOSTICS GENICARE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 02/26/2001
  HOME DIAGNOSTICS MEDHOME DIRECT BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 02/26/2001
  HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 02/26/2001
  HOME DIAGNOSTICS VITALCARE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 02/26/2001
  LIFESCAN SURESTEP PRO  
K970556 GLUCOSE General Chemistry 02/25/2001
  BAYER MICROALBUSTIX REAGENT STRIPS (OTC)  
K991315 CREATININE General Chemistry 02/14/2001
  BAYER MICROALBUSTIX REAGENT STRIPS (OTC)  
K991315 MICROALBUMIN General Chemistry 02/14/2001
  INTERNATIONAL NEWTECH DEVELOP. URINALYSIS REAGENT STRIP (10 PARAMETERS)  
K993850 URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY Urinalysis 02/05/2001
  ENTERIX !NSURE FECAL OCCULT BLOOD TEST  
K002457 FECAL OCCULT BLOOD General Chemistry 01/31/2001
  MEDTEK DIAGNOSTICS INSTACCULT  
K002930 FECAL OCCULT BLOOD General Chemistry 01/30/2001
  APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K002621 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 01/22/2001
  APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K002624 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 01/22/2001
  HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 01/22/2001
  HUMANA BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 01/22/2001
  STC TECHNOLOGIES ORASURE Q.E.D. A-150 SALIVA ALCOHOL TEST  
K894001 ALCOHOL, SALIVA Toxicology / TDM 01/22/2001
  VALU-RITE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 01/22/2001
  WEIS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 01/22/2001
  GENUA MENOPAUSE MONITOR TEST  (QUALITATIVE)
K002450 FOLLICLE STIMULATING HORMONE (FSH) Endocrinology 01/12/2001
  ACON ONE STEP PREGNANCY TEST STRIP (URINE)  
K993203 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/19/2000
  KINRAY PREFERRED PLUS BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/19/2000
  LIFESCAN SATURN BLOOD GLUCOSE MONITORING TEST STRIP  
K001441 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/19/2000
  STC TECHNOLOGIES ORASURE Q.E.D. A-350 SALIVA ALCOHOL TEST  
K903235 ALCOHOL, SALIVA Toxicology / TDM 12/19/2000
  THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM  
K000582 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/19/2000
  ACCUNATE-CHOICE  
K992397 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/13/2000
  DISCOUNT DRUG MART FOOD FAIR BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  DRUG EMPORIUM BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  DUANE READE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  EXPRESS MED BLOOD GLYCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  FACT PLUS PRO PREGNANCY TEST  
K990576 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/13/2000
  FACT PLUS SELECT PREGNANCY TEST  
K965184 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/13/2000
  GIANT EAGLE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  HELENA LABORATORIES COLOSCREEN-ES  
K003359 FECAL OCCULT BLOOD General Chemistry 12/13/2000
  KERR BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  MEDIC BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  SENTRY BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  SHOP RITE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 12/13/2000
  BECKMAN COULTER INC'S ICON 25 HCG  
K993065 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/06/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 CANNABINOIDS (THC) Toxicology / TDM 12/06/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 COCAINE METABOLITES Toxicology / TDM 12/06/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 METHAMPHETAMINES Toxicology / TDM 12/06/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 OPIATES Toxicology / TDM 12/06/2000
  BECKMAN COULTER INC'S ICON 25 HCG  
K993065 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 12/04/2000
  ZYMETX ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES  
K982429 INFLUENZA A/B Virology 12/04/2000
  AMERITEK DBEST HCG 2 IU/ML TEST KIT  
K001215 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 11/30/2000
  METRIKA DRX HBA1C PRESCRIPTION HOME USE  
K000885 GLYCOSYLATED HEMOGLOBIN (HGB A1C) General Chemistry 11/30/2000
  BRITE-LIFE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/29/2000
  LIFE MEDICAL BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/29/2000
  MEIJER BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/29/2000
  SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/29/2000
  TRUE CARE BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 11/29/2000
  METRIKA DRX PROFESSIONAL USE HEMOGLOBIN A1C TEST  
K000887 GLYCOSYLATED HEMOGLOBIN (HGB A1C) General Chemistry 11/27/2000
  MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM  
K001993 GLUCOSE General Chemistry 11/20/2000
  INVERNESS MEDICAL EARLY OVULATION PREDICTOR  (STICK)
K002867 LUTEINIZING HORMONE (LH) Endocrinology 10/23/2000
  QUIDEL QUICKVUE INFLUENZA A/B  
K991633 INFLUENZA A/B Virology 10/04/2000
  LIFESCAN SURESTEP FLEXX BLOOD GLUCOSE MONITORING SYSTEM  
K970556 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 09/18/2000
  ACON HCG URINE/SERUM ONE STEP PREGNANCY TEST DEVICE  
K993065 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 09/15/2000
  ABBOTT MEDISENSE RELION BLOOD GLUCOSE TEST SYSTEM  
K944195 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 09/14/2000
  WYNTEK DIAGNOSTICS SIGNIFY MONO TEST  (FOR WHOLE BLOOD)
K972231 INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO) General Immunology 09/07/2000
  ROCHE DIAGNOSTICS COAGUCHEK S SYSTEM  
K994349 PROTHROMBIN TIME (PT) Hematology 09/06/2000
  LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K002134 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/09/2000
  LIFESCAN ONE TOUCH IIB BLOOD GLUCOSE METER {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP} 
K001092 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/01/2000
  LIFESCAN ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP} 
K001092 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 08/01/2000
  SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K001427 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 07/27/2000
  LIFESTREAM TECHNOLOGIES PERSONAL CHOLESTEROL MONITOR  (FOR OTC USE)
K000610 CHOLESTEROL General Chemistry 07/19/2000
  UNIPATH CLEARPLAN EASY FERTILITY MONITOR  
K981207 ESTRONE-3 GLUCURONIDE Endocrinology 07/17/2000
  UNIPATH CLEARPLAN EASY FERTILITY MONITOR  
K981207 OVULATION TEST (LH) BY VISUAL COLOR COMPARISON Endocrinology 07/17/2000
  TRINITY BIOTECH UNI-GOLD H. PYLORI  
K991697 HELICOBACTER PYLORI ANTIBODIES General Immunology 07/11/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC)  
K993663 CANNABINOIDS (THC) Toxicology / TDM 07/11/2000
  WYNTEK DIAGNOSTICS OSOM ULTRA STREP A  
K992658 STREPTOCOCCUS, GROUP A Bacteriology 07/06/2000
  POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER  (FOR OTC USE)
K000586 TRIGLYCERIDE General Chemistry 06/29/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 CANNABINOIDS (THC) Toxicology / TDM 06/29/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 COCAINE METABOLITES Toxicology / TDM 06/29/2000
  WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 METHAMPHETAMINES Toxicology / TDM 06/29/2000
  WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)  
K994139 CANNABINOIDS (THC) Toxicology / TDM 06/29/2000
  WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)  
K994139 COCAINE METABOLITES Toxicology / TDM 06/29/2000
  MIZUHO USA ABSOLUTE HCG PREGNANCY TEST  
K000844 HCG, URINE Endocrinology 06/15/2000
  HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM  
K992988 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 06/09/2000
  QUIDEL QUICKVUE URINE CHECK  
K861255 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 05/23/2000
  LIFESIGN LLC STATUS STREP A  
K983386 STREPTOCOCCUS, GROUP A Bacteriology 05/17/2000
  PRINCETON BIOMEDITECH BIOSTREP A  
K983386 STREPTOCOCCUS, GROUP A Bacteriology 05/17/2000
  WYNTEK DIAGNOSTICS SIGNIFY HCG URINE TEST  
K974159 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 05/02/2000
  SA SCIENTIFIC SAS SERUM/URINE HCG  
K990684 URINE HCG BY VISUAL COLOR COMPARISON TESTS Endocrinology 04/26/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9063)  
K994237 AMPHETAMINES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9068)  
K994233 METHAMPHETAMINES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9073)  
K994219 COCAINE METABOLITES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9078)  
K994220 CANNABINOIDS (THC) Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9083)  
K994234 OPIATES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9133)  
K994236 PHENCYCLIDINE (PCP) Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9170)  
K991641 CANNABINOIDS (THC) Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9170)  
K991641 COCAINE METABOLITES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9171)  
K991824 METHAMPHETAMINES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9171)  
K991824 OPIATES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 CANNABINOIDS (THC) Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 METHAMPHETAMINES Toxicology / TDM 04/19/2000
  PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 OPIATES Toxicology / TDM 04/19/2000
  PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 AMPHETAMINES Toxicology / TDM 04/19/2000
  PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 COCAINE METABOLITES Toxicology / TDM 04/19/2000
  PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 METHAMPHETAMINES Toxicology / TDM 04/19/2000
  PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 OPIATES Toxicology / TDM 04/19/2000
  PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 PHENCYCLIDINE (PCP) Toxicology / TDM 04/19/2000
  POLYMEDCO POLY STAT A (II)  
K973111 STREPTOCOCCUS, GROUP A Bacteriology 04/13/2000
  JANT PHARMACAL H. PYLORI  
K990892 HELICOBACTER PYLORI ANTIBODIES General Immunology 04/03/2000
  MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED Urinalysis 04/03/2000
  POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER TEST STRIPS CHOLESTEROL  (FOR PROFESSIONAL USE)
K990247 CHOLESTEROL General Chemistry 04/03/2000
  ROCHE DIAGNOSTICS CORP. ACCU-CHEK ADVANTAGE METER  
K000365 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 04/01/2000
  ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMPLETE SYSTEM  
K000364 GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) General Chemistry 04/01/2000
  SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K000583