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Clinical Toxicology

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

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RecordFirmDate
TDX BARBITURATES SERUM (K892650)Abbott Laboratories1989-05-16
GDS ENZYMATIC THEOPHYLLINE REAGENT (K891761)Gds Diagnostics1989-05-16
ACA VANCOMYCIN CALIBRATOR (K892901)E.I. Dupont DE Nemours & Co., Inc.1989-05-16
DRUGS OF ABUSE URINE CALIBRATORS (K892332)Hycor Biomedical, Inc.1989-05-11
COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT (K891167)Diagnostic Products Corp.1989-05-03
ACA(R) DIGITOXIN (DGTX) METHOD (K891094)E.I. Dupont DE Nemours & Co., Inc.1989-04-26
LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3 (K892004)Bio-Rad1989-04-21
SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K890721)Actio, Inc.1989-04-10
CRACK-IT CANNABINOID SCREEN (K874390)Sakers, Inc.1989-04-10
ABUSCREEN FP BENZODIAZEPHINE REAGENT (K891697)Roche Diagnostic Systems, Inc.1989-03-31
ACCULEVEL ONE-STEP THEOPHYLLINE TEST (K885253)Syva Co.1989-03-31
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE (K885272)Sigma Chemical Co.1989-03-28
ABUSCREEN FP FOR CANNABINOIDS (K890887)Roche Diagnostic Systems, Inc.1989-03-16
ABUSCREEN FP FOR MORPHINE (K890888)Roche Diagnostic Systems, Inc.1989-03-15
ABUSCREEN FP BUFFER REAGENT (K890883)Roche Diagnostic Systems, Inc.1989-03-15
ABUSCREEN FP FOR COCAINE METABOLITE (K890885)Roche Diagnostic Systems, Inc.1989-03-13
ABUSCREEN FP FOR AMPHETAMINE (K890886)Roche Diagnostic Systems, Inc.1989-03-10
ABUSCREEN FP FOR BARBITURATES (K890884)Roche Diagnostic Systems, Inc.1989-03-09
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL: (K890957)Hycor Biomedical, Inc.1989-03-09
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES (K884528)Heraeus Kulzer, Inc.1989-03-08
DRUG CONTROL SET (K884178)Gelman Sciences, Inc.1989-02-17
DRUG STANDARD SET (K884177)Gelman Sciences, Inc.1989-02-17
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR (K890451)Syva Co.1989-02-10
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR (K890452)Syva Co.1989-02-10
DETECTABUSE DRUG CONTROLS (K890406)Eastern Laboratories, Ltd.1989-02-10
CRACK-IT CHAP SCREEN (K874389)Sakers, Inc.1989-02-07
CEDIA THEOPHYLLINE ASSAY (K884358)Microgenics Corp.1989-02-07
DU PONT ACA METHOTREXATE CALIBRATOR (K884745)E.I. Dupont DE Nemours & Co., Inc.1989-01-30
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (K880199)Sclavo, Inc.1989-01-27
ATYPICAL CHOLINESTERASE (K873496)Sclavo, Inc.1989-01-27
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE (K880049)Sclavo, Inc.1989-01-27
DOUBLE ANTIBODY SERUM BENZODIAZEPINES (K890001)Diagnostic Products Corp.1989-01-24
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS (K881344)E.I. Dupont DE Nemours & Co., Inc.1989-01-24
COAT-A-COUNT (TM) THEOPHYLLINE (K890002)Diagnostic Products Corp.1989-01-23
NEW LOW LEVEL DRUG MIXTURE CONTROL (K890030)Rapid Diagnostic Laboratories, Inc.1989-01-23
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884707)Cyberfluor, Inc.1989-01-17
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 (K885097)Diagnostic Chemicals, Ltd. (Usa)1989-01-11
COAT-A-COUNT METHAMPHETAMIN #TKMA1 (K885071)Diagnostic Products Corp.1989-01-09
BEHRING POLAROID OPUS THEOPHYLLINE (K885044)Pb Diagnostic Systems, Inc.1988-12-29
TDX METHADONE ASSAY (K884968)Abbott Laboratories1988-12-16
EZ-SCREEN CANNABINOID/COCAINE (K883105)Environmental Diagnostics, Inc.1988-12-16
MODIFICATION OF THE CEDIA DIGOXIN ASSAY (K884054)Microgenics Corp.1988-12-02
TDX BENZODIAZEPINES SERUM (K883730)Abbott Laboratories1988-11-29
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD (K883890)E.I. Dupont DE Nemours & Co., Inc.1988-11-29
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER (K883891)E.I. Dupont DE Nemours & Co., Inc.1988-11-29
TECHNICON RA-PHENOBARBITAL (K884419)Technicon Instruments Corp.1988-11-22
ANALYST THEOPHYLLINE CALIBRATOR (K884170)The DU Pont Co.1988-11-16
TURBOX THEOPHYLLINE ASSAY (K882570)Unipath , Ltd.1988-11-10
ANALYST THEOPHYLLINE ROTOR (K884002)The DU Pont Co.1988-10-31
TDX AMPHETAMINE/METHAMPHETAMINE II (K883707)Abbott Laboratories1988-10-20
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A (K883920)Syva Co.1988-10-11
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE (K884022)Syva Co.1988-10-11
TDX CANNABINOIDS-GS (K883731)Abbott Laboratories1988-10-11
MICROMEDIC CRACKPOT RIA KIT (K880674)Icn Micromedic Systems1988-10-06
BARBITURATE ENZYME IMMUNOASSAY KIT (K882663)General Diagnostics1988-09-19
EMIT (R) HVA NEGATIVE URINE (K883210)Syva Co.1988-09-19
URINE TOXICOLOGY STANDARD (K881320)Verichem Laboratories, Inc.1988-09-09
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5 (K883459)Diagnostic Products Corp.1988-09-09
DADE TDM CONTROL (K883190)Baxter Healthcare Corp1988-09-09
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE (K882496)Roche Diagnostic Systems, Inc.1988-09-02
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS (K882313)Syva Co.1988-08-29
EMIT QST CARBAMAZEPINE ASSAY (K882961)Syva Co.1988-08-29
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 (K882719)Em Diagnostic Systems, Inc.1988-08-08
REVISED DOUBLE ANTIBODY AMPHETAMINE (K882228)Diagnostic Products Corp.1988-08-08
EMIT HVA CANNABINOID 100 NG ASSAY (K882819)Syva Co.1988-08-08
EMIT HVA BARBITURATE ASSAY (K882611)Syva Co.1988-08-08
ETHYL ALCOHOL STANDARD (K882117)Verichem Laboratories, Inc.1988-08-04
EMIT HVA OPIATE ASSAY (K881941)Syva Co.1988-08-02
EMIT HVA AMPHETAMINE ASSAY (K882589)Syva Co.1988-08-02
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE (K881815)Roche Diagnostic Systems, Inc.1988-07-29
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES (K881817)Roche Diagnostic Systems, Inc.1988-07-29
ABUSCREEN(R) ONTRAK(TM) FOR THC (K881814)Roche Diagnostic Systems, Inc.1988-07-29
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES (K881816)Roche Diagnostic Systems, Inc.1988-07-28
EMIT HVA COCAINE METABOLITE ASSAY (K881942)Syva Co.1988-07-12
EMIT HVA CONTROL KIT (K881944)Syva Co.1988-07-08
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY (K881679)Ciba Corning Diagnostics Corp.1988-07-08
EMIT HVA CALIBRATOR KIT (K881943)Syva Co.1988-07-08
TDX (R) DIGOXIN NXT (K882233)Abbott Laboratories1988-07-06
MODIFIED LABELING FOR TOXI-LAB THC SCREEN (K875182)Marion Laboratories, Inc.1988-07-05
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY (K882294)Syva Co.1988-07-01
MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN (K875219)Keystone Diagnostics, Inc.1988-06-24
GDS ENZYMATIC SALICYLATE REAGENT (K882038)Gds Technology, LLC1988-06-24
MICROMEDIC MORPHINE RIA KIT (K881102)Icn Micromedic Systems1988-06-24
STAT FIX MICROWAVE IRRADIATION MEDIUM (K882362)Stat Path1988-06-22
HIGH PERFORMANCE CALIBRATORS (K875216)Rapid Diagnostic Laboratories, Inc.1988-06-22
LYPHOCHEK URINE TOXICOLOGY CONTROL (K881989)Bio-Rad1988-06-20
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL (K880145)Bio-Rad1988-06-20
EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (K881116)Diagnostic Systems1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K881991)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K881990)Bio-Rad1988-06-20
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 (K881607)Em Diagnostic Systems, Inc.1988-06-01
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT (K880823)Amersham Corp.1988-05-31
THERAPEUTIC DRUG STANDARD (K880705)Verichem Laboratories, Inc.1988-05-31
PAR(TM) BRAND DRUG OF ABUSE CONTROLS (K880152)Medical Analysis Systems, Inc.1988-05-31
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 (K881337)Em Diagnostic Systems, Inc.1988-05-27
DART PHENYTOIN (K880294)Coulter Electronics, Inc.1988-05-27
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT (K881257)Immunotech Corp.1988-05-27
GDS ENZYMATIC ACETAMINOPHEN REAGENT (K880829)Gds Technology, LLC1988-05-27
TDX (R) AMPHETAMINE CLASS (K874770)Abbott Laboratories1988-04-21
EMIT VANCOMYCIN ASSAY (K881040)Syva Co.1988-04-19
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