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Clinical Toxicology

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

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RecordFirmDate
ABBOTT AXSYM DIGITOXIN (MODIFY) (K963158)Abbott Laboratories1996-09-10
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (K962519)Behring Diagnostics, Inc.1996-09-04
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY (K962672)Princeton BioMeditech Corp.1996-08-30
CEDIA PROCAINAMIDE ASSAY (K962099)Boehringer Mannheim Corp.1996-08-27
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (K951853)Tcpi, Inc.1996-08-20
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) (K962353)Princeton BioMeditech Corp.1996-08-19
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR (K962280)Roche Diagnostic Systems, Inc.1996-08-16
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY (K962673)Princeton BioMeditech Corp.1996-08-15
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY (K962669)Princeton BioMeditech Corp.1996-08-15
PROCAINAMIDE ENZYME IMMUNOASSAY (K962463)Diagnostic Reagents, Inc.1996-08-14
VALPROIC ACID EIA TEST (K961988)Diagnostic Reagents, Inc.1996-07-16
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 (K961726)Roche Diagnostic Systems, Inc.1996-07-11
ACETAMINOPHEN SERUM TOX EIA ASSAY (K961373)Diagnostic Reagents, Inc.1996-07-08
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD (K961010)Princeton BioMeditech Corp.1996-06-28
CEDIA THEOPHYLLINE ASSAY (K961462)Boehringer Mannheim Corp.1996-06-27
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET (K962165)Roche Diagnostic Systems, Inc.1996-06-26
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (K961436)Roche Diagnostic Systems, Inc.1996-06-21
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (K961620)Roche Diagnostic Systems, Inc.1996-06-13
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP (K961325)Princeton BioMeditech Corp.1996-06-12
TRICYCLICS SERUM TOX ASSAY (K961393)Diagnostic Reagents, Inc.1996-06-12
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION (K936135)Sudormed, Inc.1996-06-10
U-DOA CONTROLS (K961724)Medical Diagnostic Technologies, Inc.1996-06-03
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 (K955633)Diagnostic Chemicals , Ltd.1996-05-24
BENZODIAZEPINE SERUM TOX EIA TEST (K960708)Diagnostic Reagents, Inc.1996-05-20
AED CALIBRATORS (K961273)Diagnostic Reagents, Inc.1996-05-15
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT (K961256)Beckman Instruments, Inc.1996-05-15
AXSYM VANCOMYCIN II (K955851)Abbott Laboratories1996-05-09
BARBITURATE SERUM TOX EIA ASSAY (K960664)Diagnostic Reagents, Inc.1996-05-06
SERUM TOX CALIBRATOR (K961372)Diagnostic Reagents, Inc.1996-05-01
SALICYLATE ASSAY (K961131)Diagnostic Reagents, Inc.1996-04-29
ACCUSIGN MET/BIOSIGN MET (K961249)Princeton BioMeditech Corp.1996-04-25
AXSYM N-ACETYLPROCAINAMIDE (K955422)Abbott Laboratories1996-04-24
INNOFLUOR QUINIDINE ASSAY SYSTEM (K955568)Oxis Intl., Inc.1996-04-04
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT (K955677)Beckman Instruments, Inc.1996-04-03
ABBOTT AXSM PROCAINAMIDE ASSAY (K955444)Abbott Laboratories1996-04-02
COCAINE METABOLITE EIA TEST (K960187)Diagnostic Reagents, Inc.1996-04-02
DOCUMENT TDM ULTRA ASSAYED CONTROL (K960244)Casco Standards1996-03-22
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (K940048)Solarcare Technologies Corp,Inc.1996-03-19
PRIMIDONE EIA TEST (K960526)Diagnostic Reagents, Inc.1996-03-18
ACS PHENYTOIN ASSAY (K955873)Ciba Corning Diagnostics Corp.1996-03-11
BARBITURATE EIA ESSAY (MODIFICATION) (K955928)Diagnostic Reagents, Inc.1996-03-11
FRONTLINE CANNABIS (K954497)Boehringer Mannheim Corp.1996-03-06
FRONTLINE OPIATES (K954498)Boehringer Mannheim Corp.1996-03-06
FRONTLINE COCAINE (K954496)Boehringer Mannheim Corp.1996-03-06
SYNCHRON SYSTEMS METHAQUALONE REAGENT (K955676)Beckman Instruments, Inc.1996-03-04
EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS (K955448)Behring Diagnostics, Inc.1996-02-23
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM (K955644)Beckman Instruments, Inc.1996-02-16
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 (K955934)Biosite Incorporated1996-02-16
VANCOMYCIN FPIA REAGENT SET (K955716)Sigma Diagnostics, Inc.1996-02-16
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS (K955935)Biosite Incorporated1996-02-15
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT (K955675)Beckman Instruments, Inc.1996-02-09
CEDIA DAU LSD CALBIRATORS (K955813)Microgenics Corp.1996-02-09
INNOFLUOR AMIKACIN ASSAY SYSTEM (K955570)Oxis Intl., Inc.1996-02-09
INNOFLUOR GENTAMICIN ASSAY SYSTEM (K955569)Oxis Intl., Inc.1996-02-09
CEDIA DAU LSD ASSAY (K955814)Microgenics Corp.1996-02-09
IL TEST CHOLINESTERASE (K943367)Instrumentation Laboratory CO1996-02-05
LYPHOCHEK BENZO/TCA CONTROL-SET B (K955153)Bio-Rad1996-02-05
BENZODIAZEPINES BY REMEDI HS (K955116)Bio-Rad1996-01-30
INNOFLUOR PHENYTOIN ASSAY SYSTEM (K955562)Oxis Intl., Inc.1996-01-24
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (K955498)Diagnostic Chemicals , Ltd.1996-01-24
INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (K955567)Oxis Intl., Inc.1996-01-24
AXSYM DIGITOXIN (K954420)Abbott Laboratories1995-12-29
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH (K954608)Boehringer Mannheim Corp.1995-12-26
DOCUMENT TDM ULTRA UNASSAYED CONTROL (K955155)Casco Standards1995-12-20
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN (K954933)Johnson & Johnson Clinical Diagnostics, Inc.1995-12-18
CARBAMAZEPINE EIA TEST (K955100)Diagnostic Reagents, Inc.1995-12-13
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL (K954799)Roche Diagnostic Systems, Inc.1995-12-13
ACS PHENOBARBITAL (K953021)Ciba Corning Diagnostics Corp.1995-12-11
STC DIAGNOSTICS LSD MICRO-PLATE EIA (K954073)Solarcare Technologies Corp,Inc.1995-11-29
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION) (K954626)Microgenics Corp.1995-11-27
AXSYM TRICYCLIC ANTIDEPRESSANTS (K953761)Abbott Laboratories1995-11-22
OPUS TDM CONTROLS (K954291)Behring Diagnostics, Inc.1995-11-20
CEDIA DAU METHADONE ASSAY (K954227)Microgenics Corp.1995-11-17
IMMULITE THEOPHYLLINE (K954569)Diagnostic Products Corp.1995-11-13
AXSYM METHADONE (K953499)Abbott Laboratories1995-11-13
AVOXIMETER 4000 (K951485)A-Vox Systems, Inc.1995-11-06
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI (K954571)Princeton BioMeditech Corp.1995-11-03
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID (K953224)Roche Diagnostic Systems, Inc.1995-10-30
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET (K945549)Princeton BioMeditech Corp.1995-10-26
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC (K952361)Princeton BioMeditech Corp.1995-10-26
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL (K954322)Medical Analysis Systems, Inc.1995-10-11
AXSYM AMPHETAMINE/METHAMPHETAMINE II (K953115)Abbott Laboratories1995-10-06
TOX PERFECT A TUBE (K953393)Chimera Research & Chemical, Inc.1995-10-06
VISUALINE II BENZODIAZEPINES (K953105)Sun Biomedical Laboratories, Inc.1995-10-05
AXSYM REA ETHANOL (K953765)Abbott Laboratories1995-09-27
AXSYM PHENYTOIN II (K953840)Abbott Laboratories1995-09-25
AXSYM DIGOXIN II (K953718)Abbott Laboratories1995-09-25
MECTEST (K945207)Meco Industries1995-09-25
ABUSCREEN ONLINE CONTROLS (K953739)Roche Diagnostic Systems, Inc.1995-09-20
ABUSCREEN ONLINE DRUG FREE URINE (K953845)Roche Diagnostic Systems, Inc.1995-09-20
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN (K953528)Roche Diagnostic Systems, Inc.1995-09-12
ACETAMINOPHEN ASSAY (K952949)Diagnostic Chemicals , Ltd.1995-09-06
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (K952839)Boehringer Mannheim Corp.1995-08-24
AXSYM ACETAMINOPHEN (K953094)Abbott Laboratories1995-08-24
AXSYM THEOPHYLLINE II (K953016)Abbott Laboratories1995-08-24
ONE STEP URINE DRUG OF ABUSE COCAINE TEST (K951892)Tcpi, Inc.1995-08-17
ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) (K952096)Tcpi, Inc.1995-08-17
THEOPHYLLINE ENZYME IMMUNOASSAY (K952596)Diagnostic Reagents, Inc.1995-08-11
AXSYM SALICYLATE (K951290)Abbott Laboratories1995-08-08
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (K952568)Beckman Instruments, Inc.1995-08-08
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