| MODIFICATION OF EMIT D.A.U. OPIATES ASSAY (K984232) | Syva Co. | 1999-01-22 |
| 'RAPID DRUG SCREEN' 9-PANEL (K983770) | American Bio Medica Corp. | 1998-12-31 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II (K983747) | Beckman Coulter, Inc. | 1998-12-30 |
| ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ (K983501) | Princeton BioMeditech Corp. | 1998-12-18 |
| ABUSCREEN ONLINE BENZ 300 CALIBRATORS (K983556) | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| ABUSCREEN ONLINE BENZ 200 CALIBRATORS (K983555) | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (K983699) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (K983701) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (K983697) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (K983703) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (K983700) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U (K982759) | OraSure Technologies, Inc. | 1998-11-20 |
| MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (K983268) | Diagnostic Reagents, Inc. | 1998-11-18 |
| DBEST COCAINE TEST KIT (K983191) | Ameritek, Inc. | 1998-11-18 |
| DBEST OPIATES TEST KIT (K983190) | Ameritek, Inc. | 1998-11-18 |
| ONTRAK TESTCUP-ER (K983388) | Roche Diagnostic Systems, Inc. | 1998-11-18 |
| DBEST METHAMPHETAMINES TEST KIT (K983189) | Ameritek, Inc. | 1998-11-18 |
| ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES (K983174) | Roche Diagnostic Systems, Inc. | 1998-11-18 |
| AUTO-LYTE BARBITURATES EIA (K982745) | OraSure Technologies, Inc. | 1998-11-18 |
| DBEST TETRAHYDROCANNABINOL TEST KIT (K983188) | Ameritek, Inc. | 1998-11-18 |
| NAPA EIA ASSAY (K983812) | Diagnostic Reagents, Inc. | 1998-11-16 |
| AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U (K982831) | OraSure Technologies, Inc. | 1998-11-12 |
| DIGOXIN IMMUNOASSAY (K983323) | Diagnostic Reagents, Inc. | 1998-11-12 |
| VANCOMYCIN EIA ASSAY (K983280) | Diagnostic Reagents, Inc. | 1998-11-06 |
| DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (K983159) | Diagnostic Reagents, Inc. | 1998-11-05 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT (K983151) | Beckman Coulter, Inc. | 1998-11-05 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I (K983209) | Beckman Coulter, Inc. | 1998-11-04 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 (K983709) | Beckman Coulter, Inc. | 1998-10-28 |
| SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR (K982935) | Beckman Coulter, Inc. | 1998-10-14 |
| DRUG CALIBRATOR II (K982871) | Dade Behring, Inc. | 1998-10-13 |
| ONTRAK TESTCUP AND TESTSTIK CONTROLS (K983387) | Roche Diagnostic Systems, Inc. | 1998-10-09 |
| ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P (K983147) | Princeton BioMeditech Corp. | 1998-09-28 |
| QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 (K982152) | Phamatech | 1998-09-21 |
| OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 (K983127) | Medical Analysis Systems, Inc. | 1998-09-14 |
| VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE (K981314) | Sun Biomedical Laboratories, Inc. | 1998-09-04 |
| 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME (K981705) | American Bio Medica Corp. | 1998-08-27 |
| ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K981801) | Princeton BioMeditech Corp. | 1998-08-25 |
| DIMENSION(R) VALPROIC (VALP) ACID METHOD (K982880) | Dade Behring, Inc. | 1998-08-25 |
| STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) (K982061) | OraSure Technologies, Inc. | 1998-08-25 |
| ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN (K982551) | Roche Diagnostic Systems, Inc. | 1998-08-18 |
| VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III (K982649) | Ortho-Clinical Diagnostics, Inc. | 1998-08-12 |
| DBEST AMPHETAMINES TEST KIT (K981504) | Ameritek, Inc. | 1998-08-06 |
| PROFILE-II MODEL 600582 (K982211) | Medtox Diagnostics, Inc. | 1998-07-29 |
| UBI MAGIWEL MARIJUANA METABOLITES (K973154) | United Biotech, Inc. | 1998-07-22 |
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K981926) | Emd Chemicals, Inc. | 1998-07-22 |
| AC/AD LINEARITY VERIFIERS (K982217) | Sc Calibrators & Controls, LLC | 1998-07-02 |
| OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 (K982024) | Medical Analysis Systems, Inc. | 1998-06-29 |
| SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (K981872) | Diagnostic Chemicals , Ltd. | 1998-06-29 |
| GENIE CUP INTEGRATED SCREENING DEVICE (K980836) | Applied Technology Ventures, LLC | 1998-06-29 |
| ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST (K981197) | Tcpi, Inc. | 1998-06-16 |
| ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP (K981771) | Princeton BioMeditech Corp. | 1998-06-12 |
| LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON (K981590) | Bio-Rad | 1998-06-10 |
| QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 (K981687) | Phamatech | 1998-06-03 |
| MICRO-STRIP FOR COCAINE METABOLITES (K981388) | Microdiagnostics, Inc. | 1998-05-29 |
| ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) (K981585) | Roche Diagnostic Systems, Inc. | 1998-05-28 |
| ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) (K981584) | Roche Diagnostic Systems, Inc. | 1998-05-28 |
| CEDIA DAU EDDP ASSAY (K980746) | Boehringer Mannheim Corp. | 1998-05-26 |
| STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) (K981341) | OraSure Technologies, Inc. | 1998-05-22 |
| MICRO-PLATE COTININE EIA (K974534) | OraSure Technologies, Inc. | 1998-05-18 |
| MICRO-PLATE COTININE EIA (K974234) | OraSure Technologies, Inc. | 1998-05-14 |
| ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. (K981059) | Diagnostic Chemicals , Ltd. | 1998-05-12 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (K981403) | Beckman Instruments, Inc. | 1998-05-08 |
| ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST (K980776) | Tcpi, Inc. | 1998-04-29 |
| ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL (K974840) | Roche Diagnostic Systems, Inc. | 1998-04-24 |
| MECTEST (K973986) | Meco Industries | 1998-04-24 |
| CEDIA DAU MULTI-DRUG CALIBRATORS (K980853) | Boehringer Mannheim Corp. | 1998-04-21 |
| LYPHOCHEK WHOLE BLOOD CONTROL (K980871) | Bio-Rad | 1998-04-06 |
| DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS (K980521) | Bayer Corp. | 1998-04-02 |
| QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 (K980865) | Phamatech | 1998-04-01 |
| ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 (K974002) | Diagnostic Chemicals , Ltd. | 1998-04-01 |
| DRUG CHECK (K980153) | Texas Immunology, Inc. | 1998-03-27 |
| MICRO-STRIP FOR AMPHETAMINE METABOLITES (K974611) | Microdiagnostics, Inc. | 1998-03-20 |
| RAPID DRUG SCREEN' 8 PANEL (K980872) | American Bio Medica Corp. | 1998-03-20 |
| IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S (K980331) | More Diagnostics | 1998-03-16 |
| ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K980249) | Princeton BioMeditech Corp. | 1998-03-13 |
| ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 (K980031) | Diagnostic Chemicals , Ltd. | 1998-03-03 |
| QUICKPAC II ONE STEP BARBITURATE TEST (K980349) | Syntron Bioresearch, Inc. | 1998-03-03 |
| SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (K980032) | Diagnostic Chemicals , Ltd. | 1998-03-02 |
| VITROS CHEMISTRY PRODUCTS CRBM SLIDES (K980283) | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-02-25 |
| QUIKSTRIP ONE STEP BENZODIAZEPINE TEST (K973269) | Drial Consultants, Inc. | 1998-02-25 |
| QUIKPAC II ONE STEP BENZODIAZEPINE TEST (K973326) | Drial Consultants, Inc. | 1998-02-24 |
| STC CANNABINOIDS MICRO-PLATE EIA (K973750) | OraSure Technologies, Inc. | 1998-02-13 |
| ACS TOBRAMYCIN (K974029) | Chiron Diagnostics Corp. | 1998-02-12 |
| QUIKSTRIP ONE STEP BARBITURATE TEST (K974712) | Syntron Bioresearch, Inc. | 1998-02-12 |
| STC METHAMPHETAMINE MICRO-PLATE EIA (K972989) | OraSure Technologies, Inc. | 1998-01-28 |
| REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE (K974699) | Consolidated Technologies, Inc. | 1998-01-22 |
| STC COCAINE METABOLITE MICRO-PLATE EIA (K973651) | OraSure Technologies, Inc. | 1998-01-02 |
| MICRO-STRIP FOR OPIATE METABOLITES (K973761) | Microdiagnostics, Inc. | 1997-12-24 |
| ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B (K974181) | Princeton BioMeditech Corp. | 1997-12-11 |
| TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS (K973784) | Biosite Incorporated | 1997-12-03 |
| ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (K973583) | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| ACE PRIMIDONE REAGENT, AED CALIBRATORS (K973582) | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| ACE VALPROIC ACID REAGENT, AED CALIBRATORS (K973581) | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| FINGERPRINT DRUG SCREENING DEVICE (K973726) | Applied Technology Ventures, LLC | 1997-11-06 |
| ACE PHENOBARBITAL REAGENT/AED CALIBRATORS (K973536) | Schiapparelli Biosystems, Inc. | 1997-11-06 |
| ELECSYS CALLCHECK DIGOXIN (K973973) | Boehringer Mannheim Corp. | 1997-11-04 |
| ACE PHENYTOIN REAGENT, AED CALIBRATORS (K973414) | Schiapparelli Biosystems, Inc. | 1997-11-04 |
| UBI MAGIWEL OPIATE METABOLITES (K973155) | United Biotech, Inc. | 1997-10-28 |
| UBI MAGIWEL COCAINE METABOLITES (K973156) | United Biotech, Inc. | 1997-10-28 |
| UBI MAGIWEL AMPHETAMINE METABOLITES (K973153) | United Biotech, Inc. | 1997-10-28 |