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Clinical Toxicology

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

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RecordFirmDate
VERDICT OPIATES (K943712)Editek, Inc.1994-11-17
VERDICT COCAINE (K943710)Editek, Inc.1994-11-17
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (K943550)Sigma Diagnostics, Inc.1994-11-17
EMIT 2000 DIGOXIN ASSAY (K943500)Syva Co.1994-11-15
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE (K944063)Sigma Diagnostics, Inc.1994-11-10
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS (K943866)Sigma Diagnostics, Inc.1994-11-10
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (K944371)Sigma Diagnostics, Inc.1994-11-10
CANNABINOID EIA ASSAY (K943998)Diagnostic Reagents, Inc.1994-11-04
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION (K944562)Microgenics Corp.1994-11-02
TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL (K943422)Utak Lab, Inc.1994-11-02
SOLOR CARE TECHNOLOGIES CORPORATION OPIATES (K941041)Solar Technologies Corp.1994-11-02
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (K943313)Sigma Diagnostics, Inc.1994-10-27
IMMULITE DIGITOXIN (K943235)Diagnostic Products Corp.1994-10-27
CEDIA DAU AMPHETAMINES ASSAY (K943993)Microgenics Corp.1994-10-21
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (K942610)Eastman Kodak Company1994-10-20
ACE CEDIA PHENOBARBITAL ASSAY (K942501)Schiapparelli Biosystems, Inc.1994-10-06
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (K942551)Medi-Tech, Inc.1994-10-06
ROCHE AMMONIA (VARIOUS) (K942048)Roche Diagnostic Systems, Inc.1994-10-04
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (K942619)Syva Co.1994-09-20
MICROLINE SCREEN FOR AMPHETAMINE (K935052)Drug Screening Systems, Inc.1994-09-16
NIDA-5/RT, DRUG OF ABUSE CONTROLS (K942041)Meditech1994-09-14
DOA-PLUS, DRUGS OF ABUSE CONTROLS (K942257)Medical Diagnostic Technologies, Inc.1994-09-14
QMS THEOPHYLLINE CS (K942991)Seradyn, Inc.1994-09-09
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (K942552)Medi-Tech, Inc.1994-09-09
PROPOXPHENE EIA TEST (K943414)Diagnostic Reagents, Inc.1994-09-09
CEDIA DAU OPIATE ASSAY (K941195)Microgenics Corp.1994-09-07
ATOMSPEC GF BLOOD LEAD WORKSTATION (K936060)Thermo Jarrell Ash Corp.Div.Thermo Inst.1994-09-06
ROCHE TDM CALIBRATION VERIFICATION TEST SET (K942114)Roche Diagnostic Systems, Inc.1994-09-02
CEDIA DAU BARBITURATE ASSAY (K942436)Microgenics Corp.1994-08-30
MICROGENICS THC CONTROL SETS (K943048)Microgenics Corp.1994-08-24
AXSYM TOBRAMYCIN (K941614)Abbott Laboratories1994-08-18
AXSYM VALPROIC ACID (K941615)Abbott Laboratories1994-08-16
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) (K935055)Roche Diagnostic Systems, Inc.1994-08-09
CEDIA DAU BENZODIAZEPINE ASSAY (K942795)Microgenics Corp.1994-08-01
CEDIA DAU MULTI-LEVEL THC ASSAY (K942337)Microgenics Corp.1994-08-01
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION (K942404)Microgenics Corp.1994-07-28
OPUS PROCAINAMIDE TEST SYSTEM (K934762)Pb Diagnostic Systems, Inc.1994-07-20
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 (K940433)Medical Analysis Systems, Inc.1994-07-20
CEDIA DAU AMPHETAMINES ASSAY (K941372)Microgenics Corp.1994-07-20
ACE CLINICAL CHEMISTRY SYSTEM (K941489)Schiapparelli Biosystems, Inc.1994-07-18
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET (K940569)Sigma Diagnostics, Inc.1994-07-13
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS (K936166)Medical Analysis Systems, Inc.1994-07-13
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (K942192)Sigma Diagnostics, Inc.1994-07-13
DOA LIQUID DRUGS OF ABUSE CONTROLS (K934498)Medical Analysis Systems, Inc.1994-07-06
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (K941440)Roche Diagnostic Systems, Inc.1994-07-06
URINE CALIBRATOR (K940935)Diagnostic Reagents, Inc.1994-07-06
AXSYM PHENOBARBITAL (K940596)Abbott Laboratories1994-06-21
AXSYM GENTAMICIN (K935376)Abbott Mfg., Inc.1994-06-21
AXSYM PHENYTOIN ASSAY (K935375)Abbott Laboratories1994-06-21
AXSYM(TM) QUINIDINE (K940682)Abbott Laboratories1994-06-21
AXSYM VANCOMYCIN (K940595)Abbott Laboratories1994-06-21
AXSYM CARBAMAZEPHINE (K935374)Abbott Laboratories1994-06-21
AXSYM THEOPHYLLINE (K935373)Abbott Laboratories1994-06-21
COBAS-FP REAGENTS AND CALIBRATORS (K941712)Roche Diagnostic Systems, Inc.1994-06-13
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN (K941142)Eastman Kodak Company1994-06-13
CEDIA DIGOXIN PLUS ASSAY (K941255)Microgenics Corp.1994-06-13
QMS GENTAMICIN ASSAY (K940376)Seradyn, Inc.1994-06-02
USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 (K940912)U.S. Drug Testing, Inc.1994-06-02
QMS CARBAMAZEPINE ASSAY (K940374)Seradyn, Inc.1994-06-02
CEDIA DAU COCAINE ASSAY (K941310)Microgenics Corp.1994-06-02
CEDIA DAU BENZODIAZEPINE ASSAY (K940159)Microgenics Corp.1994-05-27
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT (K940649)Microgenics Corp.1994-05-17
METHAQUALONE ENZYME IMMUNOASSAY (K940123)Diagnostic Reagents, Inc.1994-05-03
ACE CLINICAL CHEMISTRY SYSTEM (K940267)Schiapparelli Biosystems, Inc.1994-05-03
PARAMAX ALCOHOL REAGENT (K934275)Baxter Diagnostics, Inc.1994-04-26
CEDIA DAU CONTROLS (K934650)Medical Analysis Systems, Inc.1994-04-26
KODAK EKTACHEM DTSC II SLIDES (LI) (K934106)Eastman Kodak Company1994-04-25
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (K933572)Immunalysis Corporation1994-04-06
CEDIA DAU THC CALIBRATORS (K935795)Microgenics Corp.1994-04-06
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION (K934135)Syva Co.1994-04-06
QUALITY CONTROL MATERIAL (ASSAYED) (K935819)Columbia Diagnostics, Inc.1994-03-22
DRUGS OF ABUSE CONTROLS (K935285)Medical Diagnostic Technologies, Inc.1994-03-22
CEDIA DAU BARBITURATE ASSAY (K936030)Microgenics Corp.1994-03-22
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) (K934273)Eastman Kodak Company1994-03-21
CEDIA DAU NEGATIVE CALIBRATOR (K935793)Microgenics Corp.1994-03-14
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB (K936028)Microgenics Corp.1994-03-14
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (K936130)Roche Diagnostic Systems, Inc.1994-03-11
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS (K935904)Microgenics Corp.1994-03-11
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS (K935568)Baxter Diagnostics, Inc.1994-03-11
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (K936131)Roche Diagnostic Systems, Inc.1994-03-11
VALPROIC ACID (K936208)Seradyn, Inc.1994-03-11
QMS PHENOBARBITAL (K934388)Seradyn, Inc.1994-02-25
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE (K930844)Roche Diagnostic Systems, Inc.1994-01-27
URINE CALIBRATORS AND CONTROLS MODIFICATION (K935101)Diagnostic Reagents, Inc.1994-01-27
METHADONE ENZYME IMMUNOASSAY (K934667)Diagnostic Reagents, Inc.1994-01-26
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR (K935794)Microgenics Corp.1994-01-25
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT (K935042)Roche Diagnostic Systems, Inc.1994-01-25
CEDIA DAU 5-DRUG CALIBRATORS (K935792)Microgenics Corp.1994-01-25
CEDIA DAU MULTI-LEVEL THC ASSAY (K935591)Microgenics Corp.1994-01-13
AMPHETAMINES EIA ASSAY MODIFICATION (K934891)Diagnostic Reagents, Inc.1994-01-13
CEDIA(R) DAU OPIATE ASSAY (K935346)Microgenics Corp.1994-01-11
EMIT(R) IIC OPIATE ASSAY (K935117)Syva Co.1994-01-06
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II (K935230)Syva Co.1994-01-03
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK (K935550)Roche Diagnostic Systems, Inc.1994-01-03
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS (K934062)Biotrack, Inc.1993-12-29
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS (K932548)Roche Diagnostic Systems, Inc.1993-12-29
BIOTRACK VALPROIC ACID TEST CARTRIDGE (K934061)Biotrack, Inc.1993-12-29
CEDIA DIGOXIN PLUS ASSAY (K934168)Microgenics Corp.1993-12-29
OPUS DIGITOXIN (K935229)Pb Diagnostic Systems, Inc.1993-12-22
STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA (K934376)Solarcare, Inc.1993-12-07
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