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Clinical Toxicology

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

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RecordFirmDate
ACS GENTAMICIN (K953020)Ciba Corning Diagnostics Corp.1995-08-02
AXSYM COCAINE METABOLITE (K951289)Abbott Laboratories1995-08-02
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS (K952555)Roche Diagnostic Systems, Inc.1995-07-31
IMX DIGOXIN (K952079)Abbott Laboratories1995-07-19
STC COCAINE METABOLITE EIA (K934775)Solarcare, Inc.1995-07-14
AMPHETAMINES MICRO-PLATE EIA (K935573)Solarcare Technologies Corp,Inc.1995-07-14
OPIATES MICRO-PLATE ASSAY (K935565)Solarcare Technologies Corp,Inc.1995-07-14
OPUS PROCAINAMIDE (K951434)Behring Diagnostics, Inc.1995-07-03
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL (K952412)Dupont Medical Products1995-06-23
MSI PROCEDURE KIT (K944226)Msi, Inc.1995-06-21
CEDIA DAU BENZODIAZEPINE ASSAY (K951710)Microgenics Corp.1995-06-20
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (K951169)Ciba Corning Diagnostics Corp.1995-06-20
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY (K951059)Ciba Corning Diagnostics Corp.1995-06-19
ELI URINE CONTROLS (K951817)Elsohly Labs, Inc.1995-06-19
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K951631)Bayer Corp.1995-06-09
IL TEST DIGOXIN, PN 181761-00 (K951391)Instrumentation Laboratory CO1995-06-09
IMMUNOASSAY DRUGS OF ABUSE CONTROLS (K952056)Medi-Tech, Inc.1995-06-01
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION (K951319)Roche Diagnostic Systems, Inc.1995-06-01
DUPONT ACA DIGOXIN (DGN A) METHOD (K951441)E.I. Dupont DE Nemours & Co., Inc.1995-06-01
EMIT 2000 DIGOXIN ASSAY (K951755)Syva Co.1995-06-01
AXSYM BARBITURATES II U (K951253)Abbott Laboratories1995-05-18
AXSYM OPIATES (K951287)Abbott Laboratories1995-05-18
AXSYM BENZODIAZEPINES (K951286)Abbott Laboratories1995-05-16
AXSYM CANNABINOIDS (K951288)Abbott Laboratories1995-05-16
CEDIA DAU AMPHETAMINES ASSAY (K951154)Microgenics Corp.1995-05-08
TDX(R)/TDXFLX(R) FREE PHENYTOIN II (K950280)Abbott Laboratories1995-05-02
CEDIA DAU PROPOXYPHENE ASSAY (K951133)Microgenics Corp.1995-05-02
VISUALINE II CANNABINOIDS (THC) (K950445)Sun Biomedical Laboratories, Inc.1995-05-02
FINGERPRINT-DOA (K942836)Fingerprint Bioteck, Inc.1995-05-01
IL TEST PHENYTION CALIBRATORS (K943980)Instrumentation Laboratory CO1995-05-01
CEDIA DAU PPX/METH CALIBRATOR (K951153)Microgenics Corp.1995-04-21
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP (K945610)Princeton BioMeditech Corp.1995-04-13
MULTI-DRUG CONTROL SET (K951135)Microgenics Corp.1995-04-13
URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE (K950137)E.I. Dupont DE Nemours & Co., Inc.1995-04-13
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS (K943983)Instrumentation Laboratory CO1995-04-10
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (K950136)E.I. Dupont DE Nemours & Co., Inc.1995-04-05
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (K945187)Roche Diagnostic Systems, Inc.1995-04-05
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (K950181)E.I. Dupont DE Nemours & Co., Inc.1995-04-05
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (K950135)E.I. Dupont DE Nemours & Co., Inc.1995-03-30
TDX(R)/TDXFLX(R) PHENYTOIN II (K946328)Abbott Laboratories1995-03-28
REMEDI HS DRUG PROFILING SYSTEM (K941596)Bio-Rad1995-03-27
EMIT IIC CALIBRATORS (K935192)Syva Co.1995-03-24
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS (K950028)Sigma Diagnostics, Inc.1995-03-21
URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (K950182)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
VISUALINE II COCAINE (K950369)Sun Biomedical Laboratories, Inc.1995-03-21
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (K950134)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (K950427)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC (K941990)Bio-Rad1995-03-20
BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC (K941994)Bio-Rad1995-03-20
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD (K950180)E.I. Dupont DE Nemours & Co., Inc.1995-03-15
DUPONT ACA VANCOMYCIN (VANC) METHOD (K945125)The DU Pont Co.1995-03-10
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (K945523)Roche Diagnostic Systems, Inc.1995-03-09
DRUGS OF ABUSE CALIBRATOR (K950139)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
ABUSIGN DOA4 (K943439)Princeton BioMeditech Corp.1995-02-22
EMIT(R) IIC AMPHETAMINE ASSAY (K935352)Syva Co.1995-02-22
DRUGS OF ABUSE CONTROLS (K950138)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
EMIT IIC COCAINE METABOLITE ASSAY (K935323)Syva Co.1995-02-22
EMIT IIC BARBITURATE ASSAY (K935116)Syva Co.1995-02-22
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC (K945609)Princeton BioMeditech Corp.1995-02-22
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC (K945550)Princeton BioMeditech Corp.1995-02-22
EMIT IIC CANNABINOID ASSAY (K940158)Syva Co.1995-02-22
DIGOXIN FLEX(TM) REAGENT CARTRIDGE (K946153)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI (K945608)Princeton BioMeditech Corp.1995-02-10
PHENOBARBITAL ENZYME IMMUNOASSAY (K946210)Diagnostic Reagents, Inc.1995-02-10
STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (K944372)Solarcare, Inc.1995-02-08
ROCHE-TDM ONLEIN(TM) CONTROLS (K946119)Roche Diagnostic Systems, Inc.1995-02-07
PHENYTION EIA TEST (K945725)Diagnostic Reagents, Inc.1995-02-03
VISUALINE II MORPHINE/OPIATES/HEROIN (K943248)Sun Biomedical Laboratories, Inc.1995-01-30
IL TEST GENTAMICIN CALIBRATORS (K943982)Instrumentation Laboratory CO1995-01-25
IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 (K942687)Instrumentation Laboratory CO1995-01-25
MICROLINE SCREEN FOR BENZODIAZEPINE (K945829)Drug Screening Systems, Inc.1995-01-25
ABUSCREEN ONTRAK POSITIVE CONTROL (K943999)Roche Diagnostic Systems, Inc.1995-01-25
ABUSCREEN ONLINE(R) CALIBRATORS (K946000)Roche Diagnostic Systems, Inc.1995-01-25
IL TEST PHENOBARBITAL CALIBRATORS (K943981)Instrumentation Laboratory CO1995-01-18
IL TEST THEOPHYLLINE (K943979)Instrumentation Laboratory CO1995-01-18
CEDIA DAU OPIATE ASSAY (K945343)Microgenics Corp.1995-01-17
CEDIA DAU COCAINE ASSAY (K945345)Microgenics Corp.1995-01-17
THEOPHYLLINE CALIBRATORS (K945338)Diagnostic Reagents, Inc.1995-01-17
PHENOBARBITAL CALIBRATORS (K945316)Diagnostic Reagents, Inc.1995-01-04
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS (K944086)Beckman Instruments, Inc.1994-12-29
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST (K944075)Beckman Instruments, Inc.1994-12-29
AUTO-LYTE METHADONE DIA (K944056)Solarcare Technologies Corp,Inc.1994-12-29
PHENOBARBITAL FLEX REAGENT CARTRIDGE (K944932)Dupont Medical Products1994-12-28
ACE(TM) CEDIA(R) PHENYTOIN ASSAY (K944085)Schiapparelli Biosystems, Inc.1994-12-28
CEDIA DAU BARBITURATE ASSAY (K945344)Microgenics Corp.1994-12-28
AXSYM DIGOXIN (K944506)Abbott Laboratories1994-12-19
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (K945289)Medi-Tech, Inc.1994-12-13
ABUSCREEN ONLINE PROPOXPHENE (K945195)Roche Diagnostic Systems, Inc.1994-12-09
ABUSCREEN ONLINE CONTROLS (K945194)Roche Diagnostic Systems, Inc.1994-12-09
PHENYTOIN CALIBRATORS (K945337)Diagnostic Reagents, Inc.1994-12-07
CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS (K944604)Beckman-Diagnostic Systems Group1994-12-07
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC (K944231)Roche Diagnostic Systems, Inc.1994-12-02
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST (K944074)Beckman Instruments, Inc.1994-12-02
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (K942847)Roche Diagnostic Systems, Inc.1994-12-02
BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS (K934340)Biosite Incorporated1994-12-02
CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS (K944606)Beckman-Diagnostic Systems Group1994-11-30
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS (K944087)Beckman Instruments, Inc.1994-11-30
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY (K934003)Baxter Diagnostics, Inc.1994-11-22
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS (K944088)Beckman Instruments, Inc.1994-11-21
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS (K944076)Beckman Instruments, Inc.1994-11-21
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