| ROCHE ONLINE THEOPHYLLINE (K020740) | Roche Diagnostics Corp. | 2002-04-16 |
| UPLINK TEST SYSTEM (K020371) | OraSure Technologies, Inc. | 2002-04-03 |
| SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K020769) | Lin-Zhi International, Inc. | 2002-04-03 |
| EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY (K020441) | Dade Behring, Inc. | 2002-03-28 |
| VISUALINE BARBITURATES DIPSTRIP TEST (K020136) | Sun Biomedical Laboratories, Inc. | 2002-03-20 |
| METHADONE (K013001) | Abbott Laboratories | 2002-03-20 |
| RAPIDONE-OXY TEST (K014101) | American Bio Medica Corp. | 2002-03-20 |
| BARBITURATES (K012996) | Abbott Laboratories | 2002-03-20 |
| PROPOXYPHENE (K013100) | Abbott Laboratories | 2002-03-20 |
| KAYAK HYDROPHILIC GUIDE WIRES (K014195) | Boston Scientific Corp | 2002-03-19 |
| OPIATES (K013314) | Abbott Laboratories | 2002-03-13 |
| AMPHETAMINE/METHAMPHETAMINE (K012998) | Abbott Laboratories | 2002-03-13 |
| CANNABINOIDS (K013247) | Abbott Laboratories | 2002-03-13 |
| BENZODIAZEPINES (K013143) | Abbott Laboratories | 2002-03-13 |
| COCAINE (K013004) | Abbott Laboratories | 2002-03-13 |
| SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (K014173) | Beckman Coulter, Inc. | 2002-02-15 |
| BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS (K013959) | Bayer Diagnostics Corp. | 2002-01-29 |
| PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY (K011185) | Psychemedics Corp. | 2002-01-24 |
| ADVIA 1650 CHOLINESTERASE ASSAY (K013750) | Bayer Diagnostics Corp. | 2002-01-18 |
| RANDOX THEOPHYLLINE (K011771) | Randox Laboratories, Ltd. | 2002-01-17 |
| RANDOX CARBAMAZEPINE (K011648) | Randox Laboratories, Ltd. | 2002-01-15 |
| RANDOX VALPROIC ACID (K011649) | Randox Laboratories, Ltd. | 2002-01-15 |
| RANDOX DIGITOXIN (K012112) | Randox Laboratories, Ltd. | 2002-01-11 |
| TRIAGE TOX DRUG SCREEN, CATALOG #94000 (K012745) | Biosite Incorporated | 2002-01-10 |
| ROCHE ACETAMINOPHEN (K013757) | Roche Diagnostics Corp. | 2002-01-08 |
| ABUSCREEN ONLINE OPIATES 300 / 2000 (K013482) | Roche Diagnostics Corp. | 2001-12-21 |
| NO STEP ON SITE DEUG TEST CUP (K012390) | Drug Free Enterprises | 2001-12-18 |
| ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE (K013380) | ACON Laboratories, Inc. | 2001-12-18 |
| ETHANOL (K013538) | Abbott Laboratories | 2001-12-14 |
| SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR (K013076) | Beckman Coulter, Inc. | 2001-12-12 |
| AT HOME DRUG TEST, MODEL 9084 (K013407) | Phamatech, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9079 (K013408) | Phamatech, Inc. | 2001-12-06 |
| RANDOX PHENYTOIN (K011393) | Randox Laboratories, Ltd. | 2001-12-04 |
| AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE (K012484) | Ameditech, Inc. | 2001-11-30 |
| AMEDITECH IMMUTEST DRUG SCREEN OPIATES (K012483) | Ameditech, Inc. | 2001-11-30 |
| RAPIDONE-ECSTASY TEST (K013180) | American Bio Medica Corp. | 2001-11-26 |
| LIVESURE METHADONE SCREEN TESTS (K013796) | Pan Probe Biotech, Inc. | 2001-11-26 |
| 'RAPIDONE'-METHADONE TEST (K012164) | American Bio Medica Corp. | 2001-11-20 |
| AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE (K012585) | Ameditech, Inc. | 2001-11-16 |
| ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE (K012824) | ACON Laboratories, Inc. | 2001-11-09 |
| MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP (K013124) | Branan Medical Corp. | 2001-11-07 |
| PSYCHEMEDICS RIA COCAINE ASSAY (K010868) | Psychemedics Corp. | 2001-11-06 |
| ONTRAK TESTCARD 9 (K012396) | Roche Diagnostics Corp. | 2001-11-05 |
| ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY (K013272) | Bayer Corp. | 2001-10-25 |
| DRUGS OF ABUSE MULTI-TEST STRIP (K011952) | Microdiagnostics, Inc. | 2001-10-25 |
| AMEDITECH IMMUTEST DRUG SCREEN THC (K011813) | Ameditech, Inc. | 2001-10-22 |
| AMEDITECH IMMUTEST DRUG SCREEN COC (K011814) | Ameditech, Inc. | 2001-10-22 |
| ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE (K012595) | ACON Laboratories, Inc. | 2001-10-15 |
| TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 (K012999) | Biosite Incorporated | 2001-10-03 |
| TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 (K013002) | Biosite Incorporated | 2001-10-03 |
| LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL (K012907) | Clinical Controls | 2001-09-28 |
| IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (K012301) | Diagnostic Products Corp. | 2001-09-19 |
| RANDOX GENTAMICIN (K012978) | Randox Laboratories, Ltd. | 2001-09-18 |
| ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE (K012300) | ACON Laboratories, Inc. | 2001-09-17 |
| RANDOX THERAPEUTIC DRUG CALIBRATOR (K012318) | Randox Laboratories, Ltd. | 2001-09-12 |
| LIQUICHEK TDM CONTROL (K012741) | Bio-Rad | 2001-09-12 |
| MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET (K012541) | Branan Medical Corp. | 2001-09-04 |
| DRI ECSTASY URINE CALIBRATORS (K012109) | Microgenics Corp. | 2001-08-27 |
| DRI ECSTASY ENZYME IMMUNOASSAY (K012110) | Microgenics Corp. | 2001-08-27 |
| RANDOX HUMAN ASSSAYED DRUG CONTROL (K012319) | Randox Laboratories, Ltd. | 2001-08-24 |
| IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) (K012311) | Diagnostic Products Corp. | 2001-08-20 |
| IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) (K012312) | Diagnostic Products Corp. | 2001-08-20 |
| EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL (K011878) | Syva Co. | 2001-08-13 |
| ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (K011962) | Advantage Diagnostics Corp. | 2001-08-09 |
| EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (K012257) | Syva Co. | 2001-08-03 |
| ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE (K011673) | ACON Laboratories, Inc. | 2001-07-31 |
| ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE (K011672) | ACON Laboratories, Inc. | 2001-07-31 |
| METHADONE MICROPLATE EIA URINE APPLICATION (K011131) | Cozart Bioscience , Ltd. | 2001-07-31 |
| RADS (K011054) | Chason Healthcare, LLC | 2001-07-30 |
| ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE (K011353) | ACON Laboratories, Inc. | 2001-07-30 |
| BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 (K010734) | Branan Medical Corp. | 2001-07-30 |
| RAPID DRUG SCREEN (K012159) | American Bio Medica Corp. | 2001-07-25 |
| LIVESURE BARBITURATES SCREEN TEST (K012133) | Pan Probe Biotech, Inc. | 2001-07-20 |
| LIVESURE BENZODIAZEPINES SCREEN TESTS (K012131) | Pan Probe Biotech, Inc. | 2001-07-20 |
| CYCLOSPORINE CALIBRATOR (K011112) | Dade Behring, Inc. | 2001-07-17 |
| VISUALINE AMPHETAMINE DIPSTRIP ASSAY (K011499) | Sun Biomedical Laboratories, Inc. | 2001-07-17 |
| ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE (K010841) | ACON Laboratories, Inc. | 2001-07-09 |
| RANDOX DIGOXIN (K011302) | Randox Laboratories, Ltd. | 2001-07-02 |
| EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (K011920) | Syva Co., Dade Behring, Inc. | 2001-07-02 |
| RANDOX PHENOBARBITAL (K011303) | Randox Laboratories, Ltd. | 2001-07-02 |
| EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (K011947) | Syva Co. | 2001-07-02 |
| ADVANTAGE MARIJUANA (THC) HOME DRUG TEST (K010921) | Advantage Diagnostics Corp. | 2001-06-25 |
| COCAINE DIPSTICK TEST, MODEL D747-A (K010239) | Teco Diagnostics | 2001-06-25 |
| DRIDAU OPIATE ASSAY (K011150) | Microgenics Corp. | 2001-06-20 |
| EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (K011620) | Syva Co., Dade Behring, Inc. | 2001-06-18 |
| EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (K011605) | Syva Co., Dade Behring, Inc. | 2001-06-12 |
| LIVESURE AMPHETAMINE SCREEN TEST (K011609) | Pan Probe Biotech, Inc. | 2001-06-08 |
| VERDICT -II TCA, VERDICT-II MTD (K011545) | Medtox Diagnostics, Inc. | 2001-06-08 |
| SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (K011465) | Beckman Coulter, Inc. | 2001-06-08 |
| LIVESURE METHAMPHETAMINE SCREEN TESTS (K011610) | Pan Probe Biotech, Inc. | 2001-06-08 |
| DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (K011033) | Dade Behring, Inc. | 2001-06-07 |
| EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (K011528) | Syva Co. | 2001-06-06 |
| VERDICT -II METHAMPHETAMINE (K010226) | Medtox Diagnostics, Inc. | 2001-06-01 |
| INSTANT-VIEW METHADONE URINE DIP STRIP TEST (K010014) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST (K003881) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST (K010079) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| CEDIA DAU AMPHETAMINES/ECSTASY ASSAY (K010496) | Microgenics Corp. | 2001-05-29 |
| MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) (K003847) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST (K010125) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST (K010080) | Alfa Scientific Designs, Inc. | 2001-05-29 |