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Clinical Toxicology

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

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RecordFirmDate
HYCOR ACCUPINCH THC TEST (K901334)Hycor Biomedical, Inc.1990-05-14
SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM (K897118)Medisense, Inc.1990-05-10
COBAS-FP REAGENTS FOR VANCOMYCIN (K901759)Roche Diagnostic Systems, Inc.1990-05-02
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN (K901270)Bio-Rad1990-05-02
HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL (K901276)Diagnostic Products Corp.1990-04-26
EMIT D.A.U. AMPHETAMINE CLASS ASSAY (K900995)Syva Co.1990-04-20
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (K900707)Innotron of Oregon, Inc.1990-04-20
MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR (K900708)Innotron of Oregon, Inc.1990-04-19
MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (K900703)Innotron of Oregon, Inc.1990-04-12
MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (K900702)Innotron of Oregon, Inc.1990-04-12
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (K900706)Innotron of Oregon, Inc.1990-04-12
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (K900704)Innotron of Oregon, Inc.1990-04-12
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (K900705)Innotron of Oregon, Inc.1990-04-12
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM (K901271)Bio-Rad1990-04-11
SALIVA ALCOHOL TEST (K894001)Enzymatics C/O Burditt,Bowles,Radzius & Ruberry1990-04-05
ENZYMUN TEST(R) T4 (TOTAL THYROXINE) (K901086)Boehringer Mannheim Corp.1990-03-30
HYCOR ACCUPINCH MORPHINE TEST (K900173)Hycor Biomedical, Inc.1990-03-30
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET (K900009)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-29
POLYSTAN HEART-LUNG MACHINE SYSTEM (K894657)Polystan C/O Vitalcor, Inc.1990-03-28
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (K896780)Immunotech Corp.1990-03-23
MICRO DAU COCAINE METABOLITE TEST KIT (K896781)Immunotech Corp.1990-03-23
MILENIA (TM) DIGITOXIN (K900013)Diagnostic Products Corp.1990-03-09
ABUSCREEN FP FOR METHAMPHETAMINE (K900143)Roche Diagnostic Systems, Inc.1990-03-09
EZ-SCREEN:OPIATES (K900203)Environmental Diagnostics, Inc.1990-03-09
HYCOR ACCUPINCH COCAINE TEST (K896937)Hycor Biomedical, Inc.1990-03-06
ALPHA URINE SAMPLE (K900626)Toxi-Lab, Inc.1990-03-06
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC (K896744)Bio-Rad1990-02-23
DIGOXIN-EIA-XT (K896863)In Vitro Diagnostics, Inc.1990-02-13
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III (K892380)Baxter Healthcare Corp1990-02-08
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY (K897114)Syva Co.1990-01-18
VISION THEOPHYLLINE II (K896927)Abbott Laboratories1990-01-18
OPUS PHENOBARBITAL TEST SYSTEM (K896861)Pb Diagnostic Systems, Inc.1990-01-11
OPUS CARBAMAZEPINE TEST SYSTEM (K896860)Pb Diagnostic Systems, Inc.1990-01-02
OPUS PHENYTOIN TEST SYSTEM (K896868)Pb Diagnostic Systems, Inc.1990-01-02
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE (K895465)Baxter Healthcare Corp1989-12-27
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (K891691)Bio-Rad1989-12-19
TDX(R) BARBITURATES II ASSAY (K896550)Abbott Laboratories1989-12-19
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. (K895816)Bio-Rad1989-12-07
VISION PHENYTOIN (K896074)Abbott Laboratories1989-11-17
TARGET OPIATES-R (K890978)V-Tech, Inc.1989-11-17
TDX(R) LITES(TM) LITHIUM (K894328)Abbott Laboratories1989-11-13
CEDIA DIGITOXIN ASSAY (K896021)Microgenics Corp.1989-11-08
COMA COCAINE METABOLITE ASSAY (EIA) (K895043)Serex, Inc.1989-11-08
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (K895827)Innotron of Oregon, Inc.1989-10-31
N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT (K895572)Tudor Laboratories, Inc.1989-10-30
INNOFLUOR DIGOXIN CALIBRATOR SET (K895826)Innotron of Oregon, Inc.1989-10-30
INNOFLUOR DIGOXIN REAGENT SET (K895828)Innotron of Oregon, Inc.1989-10-30
N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (K895571)Tudor Laboratories, Inc.1989-10-25
PRIMIDONE (FPIA) KIT (K895567)Tudor Laboratories, Inc.1989-10-20
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS (K894934)Hycor Biomedical, Inc.1989-10-17
TARGET OPIATES-V (K890979)V-Tech, Inc.1989-10-04
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. (K895484)Baxter Healthcare Corp1989-10-04
VALPROIC ACID (FPIA) KIT (K895569)Tudor Laboratories, Inc.1989-10-03
KIT- CIBA CORNING L-TDM I, II, III (K893682)Ciba Corning Diagnostics Corp.1989-09-28
PRIMIDONE (FPIA) CALIBRATOR KIT (K895568)Tudor Laboratories, Inc.1989-09-28
COAT-A-COUNT(TM) FENTANYL (TKFN1) (K891605)Diagnostic Products Corp.1989-09-28
FPR GENTAMICIN KIT (K894523)Colony Laboratories, Inc.1989-09-28
EZ-BEAD DIGOXIN EIA KIT (K893843)Immunotech Corp.1989-09-28
VALPROIC ACID (FPIA) CALIBRATOR KIT (K895570)Tudor Laboratories, Inc.1989-09-28
FPR AMIKACIN KIT (K894517)Colony Laboratories, Inc.1989-09-28
FPR DIGOXIN KIT (K894521)Colony Laboratories, Inc.1989-09-25
FPR PHENYTOIN KIT (K894527)Colony Laboratories, Inc.1989-09-25
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II (K895210)Abbott Laboratories1989-09-25
FPR DIGOXIN CALIBRATOR KIT (K894522)Colony Laboratories, Inc.1989-09-25
FPR THEOPHYLLINE CALIBRATOR KIT (K894530)Colony Laboratories, Inc.1989-09-18
FPR THEOPHYLLINE KIT (K894529)Colony Laboratories, Inc.1989-09-15
FPR TOBRAMYCIN KIT (K894531)Colony Laboratories, Inc.1989-09-01
FPR TOBRAMYCIN CALIBRATOR KIT (K894532)Colony Laboratories, Inc.1989-09-01
FPR CARBAMAZEPINE CALIBRATOR KIT (K894520)Colony Laboratories, Inc.1989-08-28
FPR PHENOBARBITAL CALIBRATOR KIT (K894526)Colony Laboratories, Inc.1989-08-28
ABUSCREEN POSITIVE REFERENCE CONTROLS (K894464)Roche Diagnostic Systems, Inc.1989-08-28
FPR PHENOBARBITAL KIT (K894525)Colony Laboratories, Inc.1989-08-28
FPR CARBAMAZEPINE KIT (K894519)Colony Laboratories, Inc.1989-08-28
ADX COCAINE METABOLITE (K890788)Abbott Laboratories1989-08-25
AD X(TM) ETHANOL (K890743)Abbott Laboratories1989-08-25
ADX CANNABINOIDS (K890693)Abbott Laboratories1989-08-25
ADX TM BARBITURATES (K890690)Abbott Laboratories1989-08-25
ADX AMPHETAMINE/METHAMPHEAMINE (K890692)Abbott Laboratories1989-08-25
ADX TM BENZODIAZEPINES (K890691)Abbott Laboratories1989-08-25
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS (K894463)Roche Diagnostic Systems, Inc.1989-08-21
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD (K893913)Technicon Instruments Corp.1989-08-21
TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD (K893912)Technicon Instruments Corp.1989-08-21
EMIT CONVENIENCE PACK: DIGOXIN ASSAY (K893910)Syva Co.1989-08-21
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET (K893506)Innotron of Oregon, Inc.1989-08-15
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE (K894465)Roche Diagnostic Systems, Inc.1989-08-15
BECKMAN CHOLINESTERASE REAGENT KIT (K893583)Beckman1989-08-15
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS (K891581)Roche Diagnostic Systems, Inc.1989-08-15
INNOFLUOR CARBAMAZEPINE REAGENT SET (K893507)Innotron of Oregon, Inc.1989-08-11
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE (K894404)Syva Co.1989-08-11
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE (K893856)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC (K893858)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES (K893855)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE (K893859)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE (K893860)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE (K893857)Roche Diagnostic Systems, Inc.1989-08-03
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS (K893815)Hycor Biomedical, Inc.1989-07-25
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE (K893835)Ciba Corning Diagnostics Corp.1989-07-25
INNOFLUOR(TM) QUINDINE CALIBATOR SET (K892212)Innotron of Oregon, Inc.1989-06-09
INNOFLUOR(TM) QUINIDINE REAGENT SET (K892208)Innotron of Oregon, Inc.1989-06-09
ACA VANCOMYCIN (VANC) METHOD (K892900)E.I. Dupont DE Nemours & Co., Inc.1989-05-22
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