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Clinical Toxicology

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

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RecordFirmDate
TOXI-LAB CANNABINOID THC SCREEN (K831456)Marion Laboratories, Inc.1983-06-30
QUINIDINE REAGENT TEST KIT (K830963)Beckman Instruments, Inc.1983-06-30
EMIT QST TOBRAMYCIN CONTROL (K831417)Syva Co.1983-06-16
EMIT QST TOBRAMYCIN ASSAY (K831416)Syva Co.1983-06-08
EMIT QST GENTAMICIN ASSAY (K831304)Syva Co.1983-06-02
EMIT QST QUINIDINE ASSAY (K831355)Syva Co.1983-06-02
AMES TDA N-ACETYL-PROCAINAMIDE TEST (K831399)Miles Laboratories, Inc.1983-06-02
AMES TDA PROCAINAMIDE TEST (K831400)Miles Laboratories, Inc.1983-06-02
LIQUI-SERA ANTICONVULSANTS CONTROLS (K831278)Biodiagnostic Intl1983-05-27
EMIT QST THEOPHYLLINE ASSAY (K831272)Syva Co.1983-05-27
EMIT QST LIDOCAINE ASSAY (K831354)Syva Co.1983-05-27
GENTAMICIN TEST PACK-ACA (K831210)E.I. Dupont DE Nemours & Co., Inc.1983-05-25
WALRUS PERCUTANEOUS INTRODUCER SET (K831239)Medical Parameters, Inc.1983-05-25
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM- (K831177)American Dade1983-05-17
GENTAMICIN CALIBRATOR -ACA (K831209)E.I. Dupont DE Nemours & Co., Inc.1983-05-16
STRATUS PHENYTOIN FLUOROMETRIC ENZYME (K831154)American Dade1983-05-16
STRATUS PHENOBARBITAL FLUOROMETRIC ENZ (K830701)American Dade1983-05-13
VASCULAR CATHETER (K831191)Medrad, Inc.1983-05-09
CARBAMEZEPINE REAGENT TEST KIT (K831222)Beckman Instruments, Inc.1983-05-09
CONNECTOR TUBE (K831188)Medrad, Inc.1983-05-09
IMMUCHEM COVALENT-COAT RIA KIT (K830962)Immuchem Corp.1983-05-04
BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- (K830843)Rna Medical Corp.1983-04-28
AMES TDA VALPROIC ACID TEST (K830789)Miles Laboratories, Inc.1983-04-12
POTASSIUM DILUENT (K830636)Shaban Mfg. Co.1983-04-05
EMIT-ST PHOTOMETER & DILUTER VERIFICA (K830518)Syva Co.1983-04-05
PHASE II DIGOXIN RADIOIMMUNOASSAY KIT (K830533)Medical & Scientific Designs, Inc.1983-04-05
ABUSCREEN RADIOUMMUNOASSAY--URINE (K830462)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (K830480)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (K830460)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (K830461)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (K830482)Hoffmann-La Roche, Inc.1983-03-24
CONTOX DURG CONTROL (K830492)Kaulson Laboratories, Inc.1983-03-11
CONTOX DRUG SCREEN CONTROL (K830494)Kaulson Laboratories, Inc.1983-03-11
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (K830479)Hoffmann-La Roche, Inc.1983-03-10
TDX N-ACETYLPROCAINAMIDE (K830206)Abbott Laboratories1983-02-18
CONTOX HEAVYMETALS CONTROL (K830234)Kaulson Laboratories, Inc.1983-02-18
DILUENT, ZEROING SOLUTION & CO-OX/ISE (K823535)Shaban Mfg. Co.1983-01-28
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS (K830035)Diagnostic Products Corp.1983-01-28
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY (K823887)Syva Co.1983-01-28
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL (K830049)Syva Co.1983-01-28
ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL (K823865)Syva Co.1983-01-14
TOXI-LAB RAPID SCREEN (K823523)Marion Laboratories, Inc.1983-01-14
AMES TDA ETHOSUXIMIDE TEST (K823801)Miles Laboratories, Inc.1983-01-14
ADVANCE EMIT CAD LIDOCAINE ASSAY (K823866)Syva Co.1983-01-12
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG (K823746)Syva Co.1983-01-12
ADVANCE EMIT-AED PRIMEDONE ASSAY (K823741)Syva Co.1983-01-07
COBAS STANDARD FOR TOTAL PROTEIN (K823576)Hoffmann-La Roche, Inc.1983-01-07
ADVANCE EMIT-AED ETHOSUXIMIDE (K823745)Syva Co.1983-01-07
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC (K823740)Syva Co.1983-01-05
SOPHEIA GENTAMICIN EIA KIT (K823387)Diagnostic Products Corp.1982-12-22
AMES TDA GENTAMICIN TEST (K821669)Miles Laboratories, Inc.1982-12-15
ADVANCE EMIT(R) & TM AMIKACIN CONTROL (K823369)Syva Co.1982-12-15
ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (K823370)Syva Co.1982-12-03
BARBITURATE TEST SET #0550-050 (K823237)Stanbio Laboratory1982-11-29
ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL (K823127)Syva Co.1982-11-29
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE (K823212)Hoffmann-La Roche, Inc.1982-11-29
ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE (K823129)Syva Co.1982-11-29
ADVANCE EMIT CAD PROCAINAMIDE ASSAY (K823128)Syva Co.1982-11-29
ENZYME-TEST DIGOXIN (K823199)Icl Scientific1982-11-29
KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (K823062)American Diagnostic Corp.1982-11-10
DIGOXIN KIT (K823014)Pcl-Ria, Inc.1982-11-01
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA (K822933)Syva Co.1982-10-27
SYVA ADVANCE EMIT AED VALPROIC ACID CONT (K822934)Syva Co.1982-10-27
NETILMICIN FLUORESCENT IMMUNOASSAY (K822941)American Diagnostic Corp.1982-10-26
COAT-A-COUNT TOBRAMYCIN RIA KIT (K822858)Diagnostic Products Corp.1982-10-18
THERAPEUTIC DRUG CONTROL (K822777)Icl Scientific1982-10-08
TDX KENAMYCIN (K822808)Abbott Laboratories1982-10-08
TDX QUINIDINE (K822653)Abbott Laboratories1982-09-28
EMIT-AMD AMIKACIN ASSAY (K822657)Dade Behring, Inc.1982-09-28
ADVANCE EMIT-CAD QUINIDINE CONTROL (K822587)Syva Co.1982-09-21
ADVANCE EMIT-CAD QUINIDINE ASSAY (K822588)Syva Co.1982-09-17
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX (K821975)Ortho Diagnostic Systems, Inc.1982-08-27
LIDOCAINE FLUORESCENT IMMUNOASSAY (K822347)American Diagnostic Corp.1982-08-25
PROCEDURE #430 & REAGENTS FOR ACETAMIN (K822313)Sigma Chemical Co.1982-08-24
NEEDLE HOLDERS (K822197)Kelleher Corp.1982-08-16
VANCOMYCIN FLUORESCENT IMMUNOASSAY (K822308)American Diagnostic Corp.1982-08-16
PRIMIDONE FLUORESCENT IMMUNOASSAY (K822229)American Diagnostic Corp.1982-08-12
EMIT D.A.V. METHAQUALONE ASSAY (K822051)Syva Co.1982-07-27
EMIT D.A.V. METHAQUALONE URINE CALIBRA (K822052)Syva Co.1982-07-27
ZETAPHASE-DIG (K822053)Biological & Diagnostic Products1982-07-27
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED (K821950)Travenol Laboratories, S.A.1982-07-20
ORAL THC-CANNABINOIDS DIRECT RIA KIT (K821965)Immunalysis Corporation1982-07-20
Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. (K821973)Travenol Laboratories, S.A.1982-07-20
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY (K821945)American Diagnostic Corp.1982-07-16
ACETAMINOPHEN STAT-PAK REAGENT SET (K821969)Clin Tech Diagnostics Corp.1982-07-16
QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. (K821862)Kallestad Laboratories, Inc.1982-07-06
EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY (K821743)Syva Co.1982-07-02
125I DIGOXIN RADIOIMMUNOASSAY KIT (K821811)Cambridge Medical Technology1982-07-02
EMIT ST URINE METHAGUALONE CALIBRATOR (K821767)Syva Co.1982-06-25
MACRO-VUE CARD TEST, AMIKACIN (K821771)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-06-25
EMIT ST URINE METHAGUALONE ASSAY (K821768)Syva Co.1982-06-24
EMIT - ST URINE METHAGUALONE CONTROLS (K821766)Syva Co.1982-06-24
TDX NETILMICIN (K821698)Abbott Laboratories1982-06-22
PROTRIPTYLINE TRI-CY TEST SET (K821653)Wien Laboratories, Inc.1982-06-14
DOXEPIN TRI-CY TEST SET (K821652)Wien Laboratories, Inc.1982-06-14
DETECTION OF THEOPHYLLINE (K821544)Electro-Nucleonics Laboratories, Inc.1982-06-10
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA (K821542)Electro-Nucleonics Laboratories, Inc.1982-06-03
IPA FOR DETECTION OF PHENOBARBITAL (K821543)Electro-Nucleonics Laboratories, Inc.1982-06-03
EMIT TOX ACETAMINOPHEN CONTROL (K821380)Syva Co.1982-06-02
EMIT-TOX ACETAMINOPHEN ASSAY (K821379)Syva Co.1982-05-28
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