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Clinical Toxicology

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

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RecordFirmDate
RAICHEM CHOLINESTERASE REAGENT (K862168)Reagents Applications, Inc.1986-06-27
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM (K860464)Abbott Laboratories1986-06-17
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY (K862067)American Dade1986-06-16
EMIT CAFFEINE CONTROL (K861511)Syva / A Syntex Co.1986-06-13
EMIT CAFFEINE ASSAY (K853872)Syva Co.1986-06-13
EMIT COLUMN DIGOXIN ASSAY (K861393)Syva Co.1986-05-29
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO) (K861367)Eastman Kodak Company1986-05-29
EMIT DIGOXIN MOBILE PHASE SOLUTION (K861394)Syva Co.1986-05-29
SALICYLATE REAGENT SET (K861615)Sterling Diagnostics, Inc.1986-05-23
EMIT COLUMN DIGOXIN CALIBRATORS (K861395)Syva Co.1986-05-07
EMIT DESIPRAMINE ASSAY (K861155)Syva Co.1986-05-02
SERUM CHOLINESTERASE REAGENT SET (K860350)Sterling Diagnostics, Inc.1986-04-24
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (K860525)Roche Diagnostic Systems, Inc.1986-04-11
EMIT D.A.U. CANNABINOID 20NG ASSAY (K860500)Syva Co.1986-04-11
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL (K855227)Bioclinical Systems, Inc.1986-04-11
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS (K860919)Fisher Scientific Co., LLC1986-04-11
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 (K860641)Em Diagnostic Systems, Inc.1986-04-03
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN (K860868)Technicon Instruments Corp.1986-04-03
CEDIA DIGOXIN ASSAY (K854638)Microgenics Corp.1986-03-25
PHENOBARBITAL TEST SYSTEM (K860365)Allied Instrumentation Laboratory1986-03-17
IL TEST PHENYTOIN (K860286)Allied Instrumentation Laboratory1986-03-05
MDI QUIK TEST NARCOTICS DRUG SCREEN (K853140)Medical Diagnostics, Ca.1986-03-03
DUPONT PHENOBARBITAL ASSAY (K860304)E.I. Dupont DE Nemours & Co., Inc.1986-02-28
DUPONT PHENOBARBITAL CALIBRATOR (K860303)E.I. Dupont DE Nemours & Co., Inc.1986-02-28
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. (K860141)American Dade1986-02-11
THERAPEUTIC DRUG (TDM) CALIBRATOR (K860097)Instrumentation Laboratory CO1986-02-11
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. (K860140)American Dade1986-02-06
INTRAOCULAR PRESSURE REDUCER (K854873)Mira, Inc.1986-02-04
DETERMINATION OF CARBAMAZEPINE (K860047)Clinical Data, Inc.1986-01-22
DETERMINATION OF GENTAMICIN (K860045)Clinical Data, Inc.1986-01-22
DETERMINATION OF PHENOBARBITAL (K860046)Clinical Data, Inc.1986-01-22
DETERMINATION OF QUINIDINE (K860049)Clinical Data, Inc.1986-01-22
V-TREND DIG ENZYME IMMUNOASSAY TEST KIT (K854972)V-Tech, Inc.1986-01-22
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) (K860048)Clinical Data, Inc.1986-01-22
OSM3 HEMOXIMETER (K853990)Radiometer America, Inc.1985-12-30
IN VITRO TEST DETERMINATION OF THEOPHYLLINE (K854183)Clinical Data, Inc.1985-12-19
TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU (K854392)Windsor Laboratories, Inc.1985-12-05
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN (K854184)Clinical Data, Inc.1985-12-04
TDX R OPIATES (K854421)Abbott Laboratories1985-11-25
DEMAND ETHYL ALCOHOL (K854130)Cooper Biomedical, Inc.1985-11-05
TDX COCAINE METABOLITE (K854163)Abbott Laboratories1985-11-05
TDX AMPHETAMINE METHAMPHETAMINE (K853879)Abbott Laboratories1985-10-28
TDX BARBITURATES (K854044)Abbott Laboratories1985-10-28
VISION THEOPHYLLINE (K853834)Abbott Laboratories1985-10-15
IL TEST THEOPHYLLINE ASSAY (K853858)Allied Instrumentation Laboratory1985-10-15
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP (K854009)Roche Diagnostic Systems, Inc.1985-10-15
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL (K853933)Quantimetrix Corp.1985-10-04
EMIT QST CARBAMAZEPINE ASSAY (K853835)Syva Co.1985-10-01
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT (K852946)Miles Laboratories, Inc.1985-09-30
ALCOHOL CALIBRATORS (K853532)Diagnostic Systems1985-09-16
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I (K853547)American Dade1985-09-16
GEMSTAR IPA THEOPHYLLINE TEST KIT (K853372)Electro-Nucleonics Laboratories, Inc.1985-09-04
ENDAB PHENOBARBITAL (K852995)Immunotech Corp.1985-08-12
TD TRICYCLIC ANTIDEPRESSANTS (K853113)Abbott Laboratories1985-08-12
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS (K853010)Roche Diagnostic Systems, Inc.1985-08-07
OPTIMATE DIGOXIN TEST (K853021)Miles Laboratories, Inc.1985-08-07
ACA GENTAMICIN TEST PACK (K852672)E.I. Dupont DE Nemours & Co., Inc.1985-08-02
LYPHOCHEK DRUG FREE SERUM(HUMAN) (K852414)Bio-Rad1985-07-24
ACA TOBRAMY-CIN ANALYTICAL TEST PACK (K852671)E.I. Dupont DE Nemours & Co., Inc.1985-07-22
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE (K852573)Technicon Instruments Corp.1985-07-12
DIG RADIOIMMUNOASSAY TEST SYSTEM (K852343)M Nobird, Inc.1985-07-09
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR (K852320)Roche Diagnostic Systems, Inc.1985-07-09
EMIT IMIPRAMINE ASSAY (K844951)Syva Co.1985-06-28
EMIT DESIPRAMINE ASSAY (K844953)Syva Co.1985-06-28
EMIT AMITRIPTYLINE ASSAY (K844950)Syva Co.1985-06-28
EMIT NORTRIPTYLINE ASSAY (K844952)Syva Co.1985-06-28
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (K852317)Roche Diagnostic Systems, Inc.1985-06-25
BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (K852158)Bioprobe Intl., Inc.1985-06-25
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS (K852318)Roche Diagnostic Systems, Inc.1985-06-25
TIPSEP DIGOXIN RIA (K852291)Nuclear Diagnostics, Inc.1985-06-25
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS (K852319)Roche Diagnostic Systems, Inc.1985-06-25
GENTAMICIN KIT(FPIA) (K852013)Windsor Laboratories, Inc.1985-06-10
ACCULEVEL THEOPHYLLINE TEST(MODIFICATION) (K851741)Syva Co.1985-06-06
GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER (K852027)Advanced Biomedical Methods, Inc.1985-05-29
EMIT 700 BENZODIAZEPINE ASSAY (K851568)Syva Co.1985-05-10
VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 (K851474)Vygon Corp.1985-05-07
VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW (K851480)Vygon Corp.1985-05-07
EMIT 700 CANNABINOID 20 ASSAY (K851373)Syva Co.1985-05-01
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 (K851278)Stanbio Laboratory1985-04-17
EMIT QST PROCAINAMIDE ASSAY (K851061)Syva Co.1985-04-12
EMIT QST N-ACETYLPROCAINAMIDE ASSAY (K851060)Syva Co.1985-04-05
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C (K851032)Roche Diagnostic Systems, Inc.1985-04-03
EMIT D.A.U. PROPOXYPHENE ASSAY (K850920)Syva Co.1985-04-02
EMIT 700 METHADONE ASSAY (K850953)Syva Co.1985-04-01
ICS THEOPHYLLINE REAGENTS (K850856)Beckman Instruments, Inc.1985-03-29
COBAS FP REAGENTS FOR QUINIDINE (K850808)Roche Diagnostic Systems, Inc.1985-03-25
COBAS FP REAGENTS FOR CARBAMAZEPINE (K850807)Roche Diagnostic Systems, Inc.1985-03-22
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY (K850712)Syva Co.1985-03-20
ACCULEVEL THEOPHYLLINE TEST (K844642)Syva Co.1985-03-19
SERALYZER ARIS PHENYTOIN REAGENT STRIPS (K842092)Miles Laboratories, Inc.1985-03-19
INNOFLUOR THEOPHYLLINE (K850629)Innotron Diagnostics1985-03-12
DU PONT DIGOXIN ASSAY CALIBRATOR (K850457)E.I. Dupont DE Nemours & Co., Inc.1985-03-05
DUPONT DIGOXIN ASSAY REAGENTS (K850458)E.I. Dupont DE Nemours & Co., Inc.1985-03-05
TDX ETHOSUXIMIDE (K850174)Abbott Laboratories1985-02-06
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (K843828)Roche Diagnostic Systems, Inc.1985-02-01
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL (K843826)Roche Diagnostic Systems, Inc.1985-02-01
COBAS REAGENTS PHENOBARBITAL & PHENOBAR (K843825)Roche Diagnostic Systems, Inc.1985-02-01
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR (K843824)Roche Diagnostic Systems, Inc.1985-02-01
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (K843827)Roche Diagnostic Systems, Inc.1985-02-01
EMIT PHENYTOIN ASSAY (K844991)Syva Co.1985-01-23
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