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Clinical Toxicology

3,040 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
MAS PAR TDM (K032826)Medical Analysis Systems, Inc.2003-10-09
DIMENSION DRUG CALIBRATOR II, MODEL DC49C (K032574)Dade Behring, Inc.2003-10-06
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 (K032461)Lin-Zhi International, Inc.2003-10-03
AML HAIRCHECK-DT (COCAINE) (K023626)Quest Diagnostics, Inc.2003-09-29
ONLINE TDM CARBAMAZEPINE (K031902)Roche Diagnostics Corp.2003-09-17
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA (K023837)Princeton BioMeditech Corp.2003-09-15
BENZODIAZEPINE ENZYME IMMUNOASSAY (K032365)Lin-Zhi International, Inc.2003-09-05
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY (K023617)Microgenics Corp.2003-08-27
VISUALINE METHADONE DIPSTRIPTEST (K023856)Sun Biomedical Laboratories, Inc.2003-08-25
ROCHE ONLINE TDM VALPROIC ACID (K032049)Roche Diagnostics Corp.2003-08-22
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC (K032057)Branan Medical Corp.2003-08-21
PRECISET TDM I AND PRECISET TDM II CALIBRATORS (K031856)Roche Diagnostics Corp.2003-08-06
PRECISET DAT PLUS I CALIBRATORS (K031775)Roche Diagnostics Corp.2003-08-05
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD (K031759)ACON Laboratories, Inc.2003-08-04
EMIT II PLUS COCAINE METABOLITE ASSAY (K031512)Dade Behring, Inc.2003-07-23
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (K031870)Beckman Coulter, Inc.2003-07-15
VERDICT II, PROFILE II (K031032)Medtox Diagnostics, Inc.2003-07-14
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 (K030113)Branan Medical Corp.2003-07-02
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (K031392)Medical Analysis Systems, Inc.2003-07-01
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (K030211)Icn Biomedicals, Inc.2003-06-13
SYVA EMIT II PLUS AMPHETAMINES ASSAY (K031004)Dade Behring, Inc.2003-06-06
'RAPID ONE' - PROPOXYPHENE TEST (K030835)American Bio Medica Corp.2003-05-22
DRI COTININE EIA ASSAY (K030649)Microgenics Corp.2003-05-22
COZART EIA COTININE URINE KIT (K021944)Cozart Bioscience , Ltd.2003-05-14
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI (K023648)Sun Biomedical Laboratories, Inc.2003-05-06
NIOX ARTICLE NO: 02-1000 (DEN030001)Aerocrine AB2003-04-30
'RAPIDTEC'-5M-MULTIPLE DIP TEST (K023869)American Bio Medica Corp.2003-04-30
SYNCHRON SYSTEMS OPIATE REAGENT (K031002)Beckman Coulter, Inc.2003-04-29
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (K030405)Seradyn2003-04-28
COZART EIA COCAINE ORAL FLIUD KIT (K030234)Cozart Bioscience , Ltd.2003-04-28
ROCHE ONLINE TDM PHENYTOIN (K030428)Roche Diagnostics Corp.2003-04-28
ONLINE DAT II CANNABINOIDS II (K030213)Roche Diagnostics Corp.2003-04-11
COZART EIA OPIATES ORAL FLUID KIT (K024339)Cozart Bioscience , Ltd.2003-04-07
PRECISET DAT AMPHETAMINE (K030826)Quantimetrix Corp.2003-04-03
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (K030616)Microgenics Corp.2003-03-31
STARTOX DRUG OF ABUSE SCREENING TEST (4) (K022388)Starplex Scientific, Inc.2003-02-27
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (K030045)Olympus America, Inc.2003-02-21
WIENER LAB COLINESTERASA AA (K023992)Wiener Laboratories Saic2003-02-12
DRI PRIMIDONE CALIBRATORS (K023780)Microgenics Corp.2003-02-10
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE (K023946)ACON Laboratories, Inc.2003-02-05
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (K023712)Advantage Diagnostics Corp.2003-01-31
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) (K023795)Lin-Zhi International, Inc.2003-01-21
AMEDICA DRUG SCREEN METHAPHETAMINE TEST (K023101)Amedica Biotech, Inc.2002-12-16
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K023316)Lin-Zhi International, Inc.2002-12-16
AMEDICA DRUG SCREEN AMPHETAMINE TEST (K023104)Amedica Biotech, Inc.2002-12-16
QUICKTOX MULTIPLE DRUG DIPCARD (K023489)Branan Medical Corp.2002-12-16
METHADONE ENZYME IMMUNOASSAY (K023317)Lin-Zhi International, Inc.2002-12-12
INSTANT-VIEW TCA URINE TEST (K022693)Alfa Scientific Designs, Inc.2002-12-09
ONLINE DAT II COCAINE II (K023281)Roche Diagnostics Corp.2002-12-06
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST (K022915)Alfa Scientific Designs, Inc.2002-11-29
COBAS INTEGRA ONLINE DAT II COCAINE II (K023296)Roche Diagnostics Corp.2002-11-25
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 (K023252)Icn Biomedicals, Inc.2002-11-22
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K023184)Bayer Diagnostics Corp.2002-11-18
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST (K022501)Alfa Scientific Designs, Inc.2002-11-13
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT (K023048)Beckman Coulter, Inc.2002-11-07
AMEDICA DRUG SCREEN THC TEST (K022955)Amedica Biotech, Inc.2002-11-06
AMEDICA DRUG SCREEN COCAINE TEST (K022954)Amedica Biotech, Inc.2002-11-06
AMEDICA DRUG SCREEN OPIATES TEST (K023047)Amedica Biotech, Inc.2002-11-06
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE (K020920)Cozart Bioscience , Ltd.2002-11-05
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE (K022589)ACON Laboratories, Inc.2002-10-28
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (K023058)Seradyn2002-10-24
NICALERT (K021688)Nymox Pharmaceutical Corporation2002-10-18
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST (K022564)Alfa Scientific Designs, Inc.2002-08-30
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 (K022707)Bio-Rad2002-08-22
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 (K021887)Lin-Zhi International, Inc.2002-08-15
VERDICT-II (K022141)Medtox Diagnostics, Inc.2002-07-30
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 (K022355)Branan Medical Corp.2002-07-30
'RAPIDTEC' 5A MULTIPLE DIP TEST (K021114)American Bio Medica Corp.2002-07-23
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (K021526)ACON Laboratories, Inc.2002-07-17
ONLINE DAT II METHADONE II (K021505)Roche Diagnostics Corp.2002-07-16
COBAS INTEGRA ONLINE DAT II METHADONE II (K021512)Roche Diagnostics Corp.2002-07-16
ROCHE ONLINE GENTAMICIN (K020704)Roche Diagnostics Corp.2002-07-12
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020794)Bayer Diagnostics Corp.2002-07-11
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020792)Bayer Diagnostics Corp.2002-07-11
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K021449)Lin-Zhi International, Inc.2002-06-18
PRECISET DAT PLUS (K021393)Quantimetrix Corp.2002-06-13
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) (K020869)Worldwide Medical Corp.2002-06-11
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC (K014067)Princeton BioMeditech Corp.2002-06-10
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC (K014066)Princeton BioMeditech Corp.2002-06-10
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC (K014069)Princeton BioMeditech Corp.2002-06-10
STARTOX DRUG OF ABUSE SCREENING TEST (K021006)Starplex Scientific, Inc.2002-06-10
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) (K020395)Lin-Zhi International, Inc.2002-06-04
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) (K020368)Lin-Zhi International, Inc.2002-06-04
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 (K014247)Biosite Incorporated2002-06-03
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 (K021414)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 (K021411)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 (K021384)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 (K021415)Bio-Rad2002-05-29
LIFESIGN DOA 4 (THC/OPI/COC/MET) (K014193)Princeton BioMeditech Corp.2002-05-23
ACON ONE STEP DRUG SCREEN TEST CARD (K020771)ACON Laboratories, Inc.2002-05-15
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) (K020763)Lin-Zhi International, Inc.2002-05-10
EMIT 2000 VANCOMYCIN ASSAY (K020692)Dade Behring, Inc.2002-05-10
EMIT 2000 VANCOMYCIN CALIBRATORS (K020845)Dade Behring, Inc.2002-05-08
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE (K020313)Acon Laboratories Co.2002-05-08
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) (K020716)Rapid Diagnostics, Inc.2002-05-06
PSYCHEMEDICS RIA CANNABINOID ASSAY (K011426)Psychemedics Corp.2002-05-03
VERDICT-II PROPOXYPHENE (K020787)Medtox Diagnostics, Inc.2002-05-02
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES (K014089)Sun Biomedical Laboratories, Inc.2002-04-25
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (K020610)Bio-Rad2002-04-22
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (K013882)OraSure Technologies, Inc.2002-04-17
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