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Clinical Toxicology

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

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RecordFirmDate
TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) (K920314)Syntex Corp.1992-04-17
ACCUSCREEN ASSAY (K920018)Jk Research1992-03-19
THC URINE CALIBRATORS (K920749)Diagnostic Reagents, Inc.1992-03-18
DRUG OF ABUSE URINE CONTROL (K920477)Diagnostic Reagents, Inc.1992-03-18
SYVA EMIT II METHADONE ASSAY (K920751)Syva Co.1992-03-13
STC DIAGNOSTICS BENZOYLECGONINE EIA (K915785)Solarcare Technologies Corp,Inc.1992-03-11
URINE A CALIBRATOR (K920208)Diagnostic Reagents, Inc.1992-03-04
CEDIA DIGOXIN ASSAY (MODIFICATION) (K920214)Microgenics Corp.1992-03-02
CANNABINOID EIA TEST (K920311)Diagnostic Reagents, Inc.1992-02-27
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY (K920507)Syva Co.1992-02-27
IL TEST CANNABINOID, 35282 (K920418)Instrumentation Laboratory CO1992-02-27
EMIT D.A.U BENZODIAZEPINE ASSAY (K915501)Syva Co.1992-02-18
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL (K915516)Roche Diagnostic Systems, Inc.1992-01-28
IL TEST(TM) BENZODIAZEPINE (K914815)Instrumentation Laboratory CO1992-01-27
DIGITOXIN FPIA REAGENT SET (K915465)Sigma Diagnostics, Inc.1992-01-27
MODEL IRC PASSPORT NEBULIZER (K914251)Invacare Corp.1992-01-24
MICROLINE SCREEN FOR CANNABINOID (K914915)Drug Screening Systems, Inc.1992-01-22
OPIATE EIA ASSAY (K915180)Diagnostic Reagents, Inc.1992-01-22
SRI DIGOXIN ENZYME IMMUNOASSAY (K915602)Serono-Baker Diagnostics, Inc.1992-01-17
DIGITOXIN FPIA CALIBRATOR SET (K915464)Sigma Diagnostics, Inc.1992-01-15
CEDIA(R) CARBAMAZEPINE ASSAY (K914857)Microgenics Corp.1992-01-15
SIGMA PROCEDURE NO. 333-UV (K914777)Sigma Diagnostics, Inc.1991-12-27
DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE (K914507)Diagnostic Products Corp.1991-12-18
COCAINE METABOLITE EIA TEST (K915371)Diagnostic Reagents, Inc.1991-12-18
IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (K914171)Tech Intl. Co.1991-12-18
MICRO EIA FOR COCAINE METABOLITES (K914533)Microdiagnostics, Inc.1991-12-10
IL TEST(TM) COCAINE (K913737)Instrumentation Laboratory CO1991-12-03
MICRO EIA FOR MARIJUANA METABOLITES (K914490)Microdiagnostics, Inc.1991-11-29
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) (K915003)Syva Co.1991-11-29
IL TEST(TM DIGOXIN (K914151)Instrumentation Laboratory CO1991-11-29
SYVA EMIT D.A.U. COCAINE METABOLITE (K914973)Syva Co.1991-11-29
IMMULITE DIGOXIN (K914833)Cirrus Diagnostics, Inc.1991-11-22
UROTEST GPH (K912244)In Wha Pharmaceutical Co., Ltd.1991-11-22
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) (K914170)Bio-Rad1991-11-22
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL (K914806)Roche Diagnostic Systems, Inc.1991-11-19
IL TEST(TM) AMPHETAMINE (K913738)Instrumentation Laboratory CO1991-11-07
IL TEST(TM) OPIATE (K913742)Instrumentation Laboratory CO1991-11-07
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET (K913911)Roche Diagnostic Systems, Inc.1991-11-01
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES (K914509)Roche Diagnostic Systems, Inc.1991-11-01
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES (K914468)Roche Diagnostic Systems, Inc.1991-10-30
IL TEST(TM) DAT CAL/CONTROL SET B (K913740)Instrumentation Laboratory CO1991-10-21
IL TEST(TM) DAT CAL/CONTROL SET C (K913741)Instrumentation Laboratory CO1991-10-21
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE (K914146)Biosite Incorporated1991-10-11
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE (K912754)Roche Diagnostic Systems, Inc.1991-09-27
CEDIA(R) GENTAMICIN ASSAY (K913470)Microgenics Corp.1991-09-27
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III (K913677)Analytical Control Systems, Inc.1991-09-25
URINE AMPHETAMINE DIRECT RIA KIT (I-125) (K913866)Immunalysis Corporation1991-09-25
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (K913414)Roche Diagnostic Systems, Inc.1991-09-25
INNOFLUOR(TM) DIGITOXIN REAGENT SET (K913187)Intl. Bioclinical, Inc.1991-09-23
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS (K913123)Syva Co.1991-09-19
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (K913867)Immunalysis Corporation1991-09-19
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (K913863)Immunalysis Corporation1991-09-19
URINE THC DIRECT RIA KIT (I-125) (K913865)Immunalysis Corporation1991-09-18
EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS (K913410)Syva Co.1991-09-16
CONTROL AND LINEARITY (K910881)Gds Diagnostics1991-09-13
TDM I LINEARITY TEST SET (K913309)Casco Standards1991-09-13
IL TEST(TM) DAT CALIBRATOR A( -) (K913739)Instrumentation Laboratory CO1991-09-10
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (K913722)Roche Diagnostic Systems, Inc.1991-09-10
DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL (K913650)Duo Research, Inc.1991-09-06
DIGITOXIN (FPIA) KIT (K913240)Tudor Laboratories, Inc.1991-09-06
QMS - DIGOXIN (K913562)Seradyn, Inc.1991-08-30
INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET (K913186)Intl. Bioclinical, Inc.1991-08-30
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS (K913429)Syva Co.1991-08-26
KODAK EKTACHEM DT SLIDES (CHE) (K913198)Eastman Kodak Company1991-08-26
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS (K913190)Syva Co.1991-08-26
ABUSCREEN(R) ONLINE(TM) CONTROLS (K913336)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (K912755)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN(R) ONLINE(TM) CALIBRATORS (K913335)Roche Diagnostic Systems, Inc.1991-08-26
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS (K912365)Abbott Laboratories1991-08-16
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (K912827)Cala Diagnostics1991-08-12
CHOLINESTERASE TEST KIT (K912148)Crestat Diagnostics, Inc.1991-08-12
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ (K913107)Roche Diagnostic Systems, Inc.1991-08-12
ROCHE REAGENT FOR ETHANOL (K913125)Roche Diagnostic Systems, Inc.1991-08-12
ABUSCREEN ONLINE FOR THC (50 AND 100) (K912574)Roche Diagnostic Systems, Inc.1991-08-12
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS (K913066)Syva Co.1991-07-30
CEDIA(R) TOBRAMYCIN ASSAY (K912143)Microgenics Corp.1991-07-26
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (K912756)Roche Diagnostic Systems, Inc.1991-07-26
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS (K912757)Roche Diagnostic Systems, Inc.1991-07-26
ABUSCREEN ONLINE FOR AMPHETAMINES (K912758)Roche Diagnostic Systems, Inc.1991-07-26
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS (K912048)Roche Diagnostic Systems, Inc.1991-07-26
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (K912826)Cala Diagnostics1991-07-26
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) (K912729)Syva Co.1991-07-22
INNOFLUOR(TM) VALPROIC ACID REAGENT SET (K911688)Intl. Bioclinical, Inc.1991-07-05
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K912217)Eastman Kodak Company1991-07-01
OPUS(R) TOBRAMYCIN (K911940)Pb Diagnostic Systems, Inc.1991-07-01
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (K911613)Exmoor Plastics , Ltd.1991-06-28
ABUSCREEN FP FOR CANNABINOIDS (15-50) (K910592)Roche Diagnostic Systems, Inc.1991-06-21
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION (K911954)Bio-Rad1991-05-23
INNOFLUOR VALPROIC ACID CALIBRATOR SET (K911466)Intl. Bioclinical, Inc.1991-05-23
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION (K911724)E.I. Dupont DE Nemours & Co., Inc.1991-05-22
CEDIA(R) DIGOXIN R' ASSAY (K911941)Microgenics Corp.1991-05-15
MIRCOLINE SCREEN FOR COCAINE (K911652)Drug Screening Systems, Inc.1991-05-15
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM (K911060)Immunomatrix1991-05-08
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III (K911168)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II (K911167)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 (K910930)Analytical Control Systems, Inc.1991-05-01
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL (K905457)Consolidated Technologies, Inc.1991-04-16
UTAK LABORATORIES TOXICOLOGY CONTROL (K903061)Utak Laboratories, Inc.1991-04-12
CHALLENGE (TM) LIQ THERA DRUG CONTROLS (K910333)Medical Analysis Systems, Inc.1991-04-12
USCI ILLUMEN-8 8F PTCA GUIDING CATHETER (K910154)C.R. Bard, Inc.1991-04-09
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