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Clinical Toxicology

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

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RecordFirmDate
DRUG MIXTURE CONTROL IN URINE (K880512)Eastern Laboratories, Ltd.1988-04-05
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL (K875135)Syva Co.1988-04-05
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K880445)Bio-Rad1988-04-05
THEOPHYLLINE TEST KIT REF. #A874799 (K880291)Photec Diagnostics, Inc.1988-03-24
REVISED LABELING FOR ADX COCAINE METABOLITE (K880009)Abbott Laboratories1988-03-11
REVISED LABELING FOR ADX CANNABINOIDS (K880015)Abbott Laboratories1988-03-01
REVISED LABELING FOR ADX BARBITURATES (K880012)Abbott Laboratories1988-03-01
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA. (K880013)Abbott Laboratories1988-03-01
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K880444)Bio-Rad1988-02-25
IMMPULSE DIGOXIN ASSAY REAGENTS (K874748)Sclavo, Inc.1988-02-19
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 (K874808)Diagnostic Products Corp.1988-02-18
ABUSCREEN(R) EIA AMPHETAMINE (K874836)Roche Diagnostic Systems, Inc.1988-02-16
REVISED LABELING FOR ADX OPIATES (K880010)Abbott Laboratories1988-02-11
REVISIED LABELING FOR ADX BENZODIAZEPINES (K880014)Abbott Laboratories1988-02-11
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH (K875252)E.I. Dupont DE Nemours & Co., Inc.1988-02-03
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III (K874757)Baxter Healthcare Corp1988-02-02
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY (K874438)Baxter Healthcare Corp1988-01-21
RAICHEM(TM) ALCOHOL REAGENT (K874382)Reagents Applications, Inc.1988-01-11
REVISED LABELING FOR SYVA BARBITURATE ASSAYS (K874702)Syva Co.1988-01-05
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY (K874856)Syva Co.1988-01-05
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY (K874625)Syva Co.1987-12-22
TDXR DELTA-9-CANNABINOIDS (K874646)Abbott Laboratories1987-12-18
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY (K874703)Syva Co.1987-12-18
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY (K874578)Syva Co.1987-11-24
REVISED LABELING FOR TDX COCAINE METABOLITE (K874487)Abbott Laboratories1987-11-23
REVISED LABELING FOR TDX BENZODIAZEPINES (K874489)Abbott Laboratories1987-11-23
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA. (K874486)Abbott Laboratories1987-11-23
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS (K873183)Abbott Laboratories1987-11-23
REVISED LABELING FOR OPIATES (K874485)Abbott Laboratories1987-11-23
REVISED LABELING FOR TDX CANNABINOIDS (K874488)Abbott Laboratories1987-11-23
REVISED LABELING FOR TDX BARBITURATES (K874483)Abbott Laboratories1987-11-23
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS (K874376)Syva Co.1987-11-23
REVISED LABELING FOR CANNABINOIDS TEST KIT (K874269)Roche Diagnostic Systems, Inc.1987-11-20
REVISED LABELING FOR LSD TEST KIT (K874270)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR BENZODIAZEPINE TEST KIT (K874265)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR METHAQUALONE TEST KIT (K874272)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR AMPHETAMINE TEST KIT (K874274)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE (K874210)Roche Diagnostic Systems, Inc.1987-11-13
ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN (K874213)E.I. Dupont DE Nemours & Co., Inc.1987-11-13
EMIT TOBRAMYCIN ASSAY (K874223)Syva Co.1987-11-13
REVISED LABELING FOR MORPHINE TEST KIT (K874268)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR COCAINE/COCAINE META. TEST (K874271)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR BARBITURATE TEST KIT (K874266)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR AMPHETAMINE TEST KIT (K874273)Roche Diagnostic Systems, Inc.1987-11-13
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95 (K874101)Em Diagnostic Systems, Inc.1987-11-09
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95 (K874102)Em Diagnostic Systems, Inc.1987-11-05
CANNABINOID ENZYME IMMUNOASSAY KIT (K872882)General Diagnostics1987-11-03
REVISED LABELING FOR SYVA AMPHETAMINE ASSAY (K874080)Syva Co.1987-10-29
EASY-TEST SALICYLATE (SAL) #16691 (K873425)Em Diagnostic Systems, Inc.1987-10-29
QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 (K873011)Quantimetrix Medical Industries1987-10-29
EMIT QST GENTAMICIN ASSAY (K873855)Syva Co.1987-10-29
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 (K873426)Em Diagnostic Systems, Inc.1987-10-29
REVISED LABELING FOR SYVA OPIATE ASSAYS (K873898)Syva Co.1987-10-29
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95 (K873436)Em Diagnostic Systems, Inc.1987-10-29
REVISED LABELING FOR SYVA CANNABINOID ASSAYS (K874079)Syva Co.1987-10-28
REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY (K874201)Syva Co.1987-10-28
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS (K874156)Syva Co.1987-10-28
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS (K874199)Syva Co.1987-10-28
REVISED LABELING FOR SYVA METHADONE ASSAYS (K873899)Syva Co.1987-10-28
EMIT GENTAMICIN ASSAY (K873854)Syva Co.1987-10-28
CARBAMAZEPINE (FPIA) CALIBRATOR KIT (K873281)Windsor Laboratories, Inc.1987-10-28
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS (K874200)Syva Co.1987-10-28
BAKER TDM THEOPHYLLINE ASSAY (K873596)Baker Instructions Corp.1987-10-20
ACA URINE BARBITURATES SCREEN METHOD (K873623)E.I. Dupont DE Nemours & Co., Inc.1987-10-20
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE (K873758)Diagnostic Products Corp.1987-10-15
LABELING CHANGE COAT-A-COUNT METHAQUALONE (K873759)Diagnostic Products Corp.1987-10-15
LABELING CHANGE BARBITURATES IN URINE (K873754)Diagnostic Products Corp.1987-10-15
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE (K873757)Diagnostic Products Corp.1987-10-15
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE (K873750)Diagnostic Products Corp.1987-10-15
LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE (K873751)Diagnostic Products Corp.1987-10-15
LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY (K873755)Diagnostic Products Corp.1987-10-15
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY (K873752)Diagnostic Products Corp.1987-10-15
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE (K873753)Diagnostic Products Corp.1987-10-15
ACA URINE DRUGS OF ABUSE CONTROL (K873539)E.I. Dupont DE Nemours & Co., Inc.1987-10-07
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD (K873538)E.I. Dupont DE Nemours & Co., Inc.1987-10-02
ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH (K873622)E.I. Dupont DE Nemours & Co., Inc.1987-10-02
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL (K873037)Diagnostic Products Corp.1987-10-02
QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (K873467)Quantimetrix Medical Industries1987-09-29
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 (K873350)Em Diagnostic Systems, Inc.1987-09-29
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY (K873282)Windsor Laboratories, Inc.1987-09-22
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 (K873349)Em Diagnostic Systems, Inc.1987-09-22
ACA URINE DRUGS OF ABUSE CALIBRATOR (K872392)E.I. Dupont DE Nemours & Co., Inc.1987-09-14
IQ DIGOXIN (K864223)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-08-28
CEDIA DIGOXIN CR ASSAY (K872583)Microgenics Corp.1987-08-28
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 (K872321)Em Diagnostic Systems, Inc.1987-08-28
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (K872563)Innotron of Oregon, Inc.1987-08-21
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET (K872562)Innotron of Oregon, Inc.1987-08-17
INNOFLUOR VANCOMYCIN REAGENT SET (K872579)Innotron of Oregon, Inc.1987-08-17
TDXR FLECAINIDE (K872175)Abbott Laboratories1987-08-13
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD (K872391)E.I. Dupont DE Nemours & Co., Inc.1987-08-10
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET (K872349)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR PHENYTOIN CALIBRATOR SET (K872142)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET (K872461)Innotron of Oregon, Inc.1987-07-21
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (K872397)Roche Diagnostic Systems, Inc.1987-07-21
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET (K872462)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET (K872463)Innotron of Oregon, Inc.1987-07-21
ETHANOL CALIBRATOR (K872181)American Monitor Corp.1987-07-21
INNOFLUOR VANCOMYCIN CALIBRATOR SET (K872644)Innotron of Oregon, Inc.1987-07-21
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 (K872330)Em Diagnostic Systems, Inc.1987-07-09
DIGOXIN FPIA CALIBRATORS (K872328)Sigma Chemical Co.1987-07-07
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