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Clinical Toxicology

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

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RecordFirmDate
SYVA ADVANCE EMIT PHENYTOIN ASSAY (K844990)Syva Co.1985-01-23
EMIT QST ACETAMINOPHEN ASSAY (K844962)Syva Co.1985-01-18
DU PONT TOBRAMYCIN ASSAY REAGENTS (K850058)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
EMIT IMIPRAMINE/DESIPRAMINE CONTROL (K844945)Syva Co.1985-01-18
DU PONT TOBRAMYCIN ASSAY CALIBRATOR (K850057)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
DU PONT GENTAMICIN ASSAY CALIBRATOR (K850059)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
DU PONT GENTAMICIN ASSAY REAGENTS (K850060)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL (K844946)Syva Co.1985-01-18
STAT/PB REAGENT (K843839)Tri-Tech, Inc.1985-01-03
EMIT QST ETHOSUXIMIDE ASSAY (K844204)Syva Co.1984-12-11
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM (K844170)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-11
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE (K844171)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-10
TDX SALICYLATE (K844070)Abbott Laboratories1984-11-27
ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT (K844167)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-27
ETHANOL CONTROLS LOW & HIGH E5133/E5258 (K843872)Sigma Chemical Co.1984-10-31
ORAL THC-CANNABINOIDS DIRECT RIA KIT (K843534)Immunalysis Corporation1984-10-30
COBAS FP TDM CONTROLS (K843913)Roche Diagnostic Systems, Inc.1984-10-30
HUMAN SERUM ANTICONVULSANT DRUG CONTROL (K843818)Quantimetrix Corp.1984-10-30
SALICYLATE ASSAY KIT (K842158)Diagnostic Chemicals, Ltd. (Usa)1984-10-22
PHENYTOIN ACA ANALYTICAL TEST PACK (K843209)E.I. Dupont DE Nemours & Co., Inc.1984-10-11
EMIT D.A.U. COCAINE ASSAY (K843556)Syva Co.1984-10-05
HUMAN SERUM CARDIOACTIVE DRUG CONTROL (K843679)Quantimetrix Corp.1984-10-05
EMIT 700 METHAQUALONE ASSAY (K843605)Syva Co.1984-10-05
EMIT 700 CANNABINOID CONTROL SET (K843419)Syva Co.1984-10-05
EMIT 700 CONTROL SET B (K843508)Syva Co.1984-09-28
EMIT D.A.U. BENZODIAZEPINE ASSAY (K842815)Syva Co.1984-09-26
THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (K842585)Windsor Laboratories, Inc.1984-09-26
EMIT D.A.U. OPIATE ASSAY (K842677)Syva Co.1984-09-26
PHENYTOIN KIT FLUORESCENCE POLARIZATION (K842586)Windsor Laboratories, Inc.1984-09-26
EMIT 700 CALIBRATOR B (K843507)Syva Co.1984-09-26
EMIT D.A.U. AMPHETAMINE ASSAY (K842674)Syva Co.1984-09-26
EMIT D.A.U. METHADONE ASSAY (K842676)Syva Co.1984-09-26
EMIT D.A.U. BARBITURATE ASSAY (K842675)Syva Co.1984-09-26
STRATUS LIDOCAINE FLUOROMETRIC ENZYME (K843184)American Dade1984-09-26
EMIT 700 CANNABINOID CALIBRATOR (K843420)Syva Co.1984-09-26
EMIT 700 CANNABINOID ASSAY (K843421)Syva Co.1984-09-25
EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT (K843458)Syva Co.1984-09-20
AMIKACIN CALIBRATOR ACA (K843210)E.I. Dupont DE Nemours & Co., Inc.1984-09-14
ETHYL ALCOHOL ASSAY KIT (K843378)Diagnostic Chemicals, Ltd. (Usa)1984-09-14
EMIT 700 BARBITURATE ASSAY (K843418)Syva Co.1984-09-14
EMIT 700 OPIATE ASSAY (K843162)Syva Co.1984-09-14
STRATUS QUINIDINE FLUOROMETRIC ENZYME (K843237)American Dade1984-09-12
EMIT 700 CALIBRATOR A (K843163)Syva Co.1984-09-12
AMIKACIN ANALYTICAL TEST PACK ACA (K843211)E.I. Dupont DE Nemours & Co., Inc.1984-09-12
SALICYLATE TEST (K843180)Sclavo, Inc.1984-09-07
ACA BARBITURATES SCREEN ANALY TEST PACK (K842783)E.I. Dupont DE Nemours & Co., Inc.1984-09-07
EMIT D.A.U. LOW & MED. CALIBRATORS B (K842816)Syva Co.1984-09-05
MINGO LOG 7 (K843440)Siemens Elema AB1984-09-04
EMIT 700 COCAINE METABOLITE ASSAY (K843160)Syva Co.1984-08-29
TDX DISOPYRAMIDE (K842713)Abbott Laboratories1984-08-29
EMIT 700 CONTROL SET A (K843161)Syva Co.1984-08-29
AMES TDA PHENOBARBITAL TEST (K842592)Miles Laboratories, Inc.1984-08-17
TDX DIGITOXIN (K842280)Abbott Laboratories1984-08-16
IMMPULSE DIGOXIN ASSAY REAGENTS (K842571)Aktis Corp.1984-08-16
ACA ACETAMINOPHEN ANALYTICAL TEST PACK (K842548)E.I. Dupont DE Nemours & Co., Inc.1984-08-16
EPSILON DIGOXIN TEST KIT (K842655)Beckman Instruments, Inc.1984-08-16
ACA BENZODIAZEPINES SCREEN TEST PK (K842387)E.I. Dupont DE Nemours & Co., Inc.1984-08-15
ACA BARBITURATES SCREEN/BENZODIAZEPIN (K842386)E.I. Dupont DE Nemours & Co., Inc.1984-08-15
VENTREZYME PHENOBARBITAL KIT IMMUNO (K842264)Ventrex Laboratories, Inc.1984-08-14
SOPHEIA/MP DIGITOXIN EIA KIT (K842578)Diagnostic Products Corp.1984-08-12
HEART - AID ALS, 95 (K841556)Cardiac Resucitator Corp.1984-07-19
STRATUS PRIMIDONE FLOROMETRIC ENZY (K842196)American Dade1984-07-11
VENTREZYME PHENYTOIN KIT IMMUNOASSAY (K842161)Ventrex Laboratories, Inc.1984-07-09
CANNU-SKREEN-PRELIMINARY (K841831)Biochemical Diagnostic, Inc.1984-07-06
EMIT D.A.U. URINE CANNABINOID CALIBRA (K834457)Syva Co.1984-06-22
EMIT D.A.U. URINE CANNABINOID ASSAY (K834458)Syva Co.1984-06-21
EMIT ST URINE CANNABINOID ASSAY (K841238)Syva Co.1984-06-21
INNOFLOUR GENTAMICIN (K841865)Innotron Diagnostics1984-05-31
INNOFLOUR TOBRAMYCIN (K841866)Innotron Diagnostics1984-05-31
INNOFLUOR PHENOBARBITAL (K841707)Innotron Diagnostics1984-05-23
INNOFLUOR PHENYTOIN (K841706)Innotron Diagnostics1984-05-22
DUPONT THEOPHYLLINE ASSAY KIT (K841656)E.I. Dupont DE Nemours & Co., Inc.1984-05-22
COMA TOXICOLOGY CONTROL (K841439)American Dade1984-05-16
DUPONT THEOPHYLLINE DIT CALIBRATOR (K841655)E.I. Dupont DE Nemours & Co., Inc.1984-05-16
TDX ACETAMINOPHEN (K840941)Abbott Laboratories1984-05-11
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN (K841533)E.I. Dupont DE Nemours & Co., Inc.1984-05-11
OPTIMATE DIGOXIN TEST (K841582)Miles Laboratories, Inc.1984-05-11
IMMPULSE GENTAMICIN ASSAY REAGENTS (K841162)Paragon Diagnostics, Inc.1984-05-02
IMMPULSE AMIKACIN ASSAY REAGENTS (K841161)Paragon Diagnostics, Inc.1984-05-02
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES (K841532)E.I. Dupont DE Nemours & Co., Inc.1984-05-02
EMIT QST PRIMIDONE ASSAY (K840939)Syva Co.1984-04-24
ACA DIGOXIN CALLIBRATOR (K841108)E.I. Dupont DE Nemours & Co., Inc.1984-04-19
ACA DIGOXIN ANALYTICAL TEST PACK (K841107)E.I. Dupont DE Nemours & Co., Inc.1984-04-19
PARAMAX ALCOHOL REAGENT (K840769)American Dade1984-04-13
TDX ETHANOL (K840826)Abbott Laboratories1984-04-13
THERACHEM TDC THERAPEUTIC DRUG CONTROL (K840921)Fisher Diagnostics1984-04-05
IMMPULSE TOBRAMYCIN ASSAY REAGENTS (K840847)Paragon Diagnostics, Inc.1984-04-04
QUINIDINE ANALYTICAL TEST PACK (K840596)E.I. Dupont DE Nemours & Co., Inc.1984-04-04
IMMPULSE THEOPHYLLINE ASSAY REAGENTS (K840758)Paragon Diagnostics, Inc.1984-04-04
AMIKACIN REAGENT TEST KIT (K840647)Beckman Instruments, Inc.1984-04-02
EMIT QST AMIKACIN ASSAY (K840193)Syva Co.1984-03-23
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY (K840461)Corning Medical & Scientific1984-03-23
DETERMIN. OF SALICYLATE IN SERUM/PLAST (K840243)Sigma Chemical Co.1984-03-23
TOBRAMYCIN REAGENT (K832763)Biosan Laboratories, Inc.1984-03-23
EMIT ST SERUM ETHYL ALCOHOL ASSAY (K840400)Syva Co.1984-03-23
QUINIDINE CALIBRATOR (K840597)E.I. Dupont DE Nemours & Co., Inc.1984-03-23
EMIT ST URINE METHAQUALONE ASSAY (K840164)Syva Co.1984-03-22
EMIT ST URINE ETHYL ALCOHOL ASSAY (K840171)Syva Co.1984-03-19
EMIT ST SERUM BARBITURATE ASSAY (K840194)Syva Co.1984-03-19
EMIT ST URINE METHADONE ASSAY (K840060)Syva Co.1984-03-19
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