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Clinical Toxicology

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

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RecordFirmDate
AUTO-LYTE COTININE EIA (K972481)OraSure Technologies, Inc.1997-10-21
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (K973535)Schiapparelli Biosystems, Inc.1997-10-20
ACCUMETER THEOPHYLLINE TEST (K972495)Chemtrak, Inc.1997-10-10
ELECSYS DIGOXIN (K973112)Boehringer Mannheim Corp.1997-10-10
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON (K973075)Roche Diagnostic Systems, Inc.1997-10-09
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST (K973047)Drial Consultants, Inc.1997-10-02
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION (K972891)Roche Diagnostic Systems, Inc.1997-10-01
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K973054)Emd Chemicals, Inc.1997-10-01
ALCOHOL REAGENT SET (K972725)Pointe Scientific, Inc.,1997-09-25
QUICKSCREEN ONE STEP THC SCREENING TEST (K973122)Phamatech1997-09-25
SYNCHRON SYSTEMS METHADONE REAGENT (K973069)Beckman Instruments, Inc.1997-09-22
LIDOCAINE EIA ASSAY (K973102)Diagnostic Reagents, Inc.1997-09-12
LEADCARE BLOOD LEAD TESTING SYSTEM (K971640)Esa, Inc.1997-09-09
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065) (K972556)Phamatech1997-09-02
QUIKPAC II ONE STEP COCAINE TEST (K972059)Drial Consultants, Inc.1997-08-28
50NG/ML COCAINE METABOLITE CALIBRATOR (K972835)Diagnostic Reagents, Inc.1997-08-28
QUICK SCREEN ONE STEP AMPHETAMINE TEST (K972577)Phamatech1997-08-20
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) (K972619)Phamatech1997-08-20
QUIKSTRIP ONE STEP OPIATES TEST (K972571)Drial Consultants, Inc.1997-08-20
VIGIL TDM CONTROLS (K972819)Beckman Instruments, Inc.1997-08-13
VISUALINE II METHAMPHETIMINE (K972032)Sun Biomedical Laboratories, Inc.1997-08-12
QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) (K972618)Phamatech1997-08-08
QUIKPAC II ONE STEP OPIATE TEST (K972405)Drial Consultants, Inc.1997-08-08
AQ ONE STEP COCAINE TEST (K972384)Bionike Laboratories, Inc.1997-08-06
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (K972609)Bio-Rad1997-08-06
METHADONE EIA ASSAY (K972526)Diagnostic Reagents, Inc.1997-08-04
INNOFLUOR GENTAMICIN ASSAY SYSTEM (K972331)Oxis Intl., Inc.1997-08-01
DIGOXIN DG-II FPIA REAGENT SET (K972794)Sigma Diagnostics, Inc.1997-07-31
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS (K972132)Sigma Diagnostics, Inc.1997-07-30
CEDIA DIGOXIN CALIBRATORS (K972433)Boehringer Mannheim Corp.1997-07-24
OPUS ETHANOL (K972011)Behring Diagnostics, Inc.1997-07-22
QUIKSTRIP ONE STEP COCAINE TEST (K971926)Drial Consultants, Inc.1997-07-14
ACS DIGITOXIN (K970546)Chiron Diagnostics Corp.1997-07-14
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (K972330)Oxis Intl., Inc.1997-07-14
PRECINORM TDM CONTROLS (K971060)Boehringer Mannheim Corp.1997-07-07
ONE STEP MORPHINE CARD TEST (K970579)Teco Diagnostics1997-07-03
ONE STEP MARIJUANA CARD TEST (K970548)Teco Diagnostics1997-07-03
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971716)Bayer Corp.1997-06-27
QUIKSTRIP ONE STEP METHAMPHETAMINE (K970395)Drial Consultants, Inc.1997-06-26
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (K971600)Behring Diagnostics, Inc.1997-06-25
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST (K971841)Bionike Laboratories, Inc.1997-06-25
EMIT II OPIATES 300/2000 ASSAY (K971596)Behring Diagnostics, Inc.1997-06-25
LYPHOCHEK REMEDI CONTROL (K972174)Bio-Rad1997-06-24
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971713)Bayer Corp.1997-06-11
AQ OPIATES (MORPHINE) TEST (K971361)Bionike Laboratories, Inc.1997-06-06
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR (K971506)Beckman Instruments, Inc.1997-06-03
QUIKSTRIP ONE STEP AMPHETAMINE TEST (K971218)Drial Consultants, Inc.1997-05-30
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 (K971691)Bio-Rad1997-05-30
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL (K971534)Beckman1997-05-21
CEDIA DIGOXIN II (K970883)Boehringer Mannheim Corp.1997-05-21
QUIKPAC II ONE STEP AMPHETAMINE TEST (K971109)Drial Consultants, Inc.1997-05-14
CEDIA DIGOXIN (K970881)Boehringer Mannheim Corp.1997-05-14
QUICKPAC II ONE STEP METHAMPHETAMINE TEST (K970724)Drial Consultants, Inc.1997-05-13
INNOFLOUR CALIBRATOR REAGENT SET (K970509)Oxis Intl., Inc.1997-05-12
INNOFLOUR TOPIRAMATE REAGENT SET (K970510)Oxis Intl., Inc.1997-05-12
INNOFLUOR TOPIRAMATE CONTROL SET (K970517)Oxis Intl., Inc.1997-05-12
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS (K971287)Beckman Instruments, Inc.1997-05-08
IMMULITE CANNABINOIDS (K963916)Diagnostic Products Corp.1997-04-28
PARAMAX SALICYLATE REAGENT (K964715)Dade Intl., Inc.1997-04-25
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (K971210)Beckman Instruments, Inc.1997-04-17
RAPID DRUG SCREEN (K964900)American Bio Medica Corp.1997-04-14
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) (K971058)Medical Analysis Systems, Inc.1997-04-08
IMMULITE COCAINE METABOLITE (K963918)Diagnostic Products Corp.1997-04-08
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST (K970265)Drial Consultants, Inc.1997-04-08
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL (K970666)Bio-Rad1997-03-10
IMMULITE OPIATES SCREEN/CONTROL MODULE (K962323)Diagnostic Products Corp.1997-03-10
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST (K963654)Syntron Bioresearch, Inc.1997-02-28
QUICKPAC II ONE STEP MARIJUANA (THC) TEST (K963207)Drial Consultants, Inc.1997-02-20
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY (K964765)Chiron Diagnostics Corp.1997-02-14
IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS (K964009)Beckman Instruments, Inc.1997-02-11
DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 (K964771)Dyna-Tek Industries1997-02-04
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS (K963673)Beckman Instruments, Inc.1997-02-04
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (K964670)Roche Diagnostic Systems, Inc.1997-02-04
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 (K965157)Boehringer Mannheim Corp.1997-01-17
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM (K964587)Bayer Corp.1997-01-13
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964116)Bayer Corp.1996-12-24
QUINIDINE ENZYME IMMUNOASSAY (K964212)Diagnostic Reagents, Inc.1996-12-18
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964442)Bayer Corp.1996-12-18
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 (K963062)Beckman Instruments, Inc.1996-12-13
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964068)Bayer Corp.1996-12-13
NICCHECK I (K963733)Dynagen, Inc.1996-12-13
CEDIA DAU BENZODIAZEPINE ASSAY (K962734)Boehringer Mannheim Corp.1996-12-10
DIGOXIN ENZYME IMMUNOASSAY (K963835)Diagnostic Reagents, Inc.1996-12-10
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (K961656)Eqm Research, Inc.1996-11-26
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL (K964422)Roche Diagnostic Systems, Inc.1996-11-25
CEDIA PHENYTOIN II ASSAY (K963840)Boehringer Mannheim Corp.1996-11-20
CEDIA DAU OPIATE 2K ASSAY (K962795)Boehringer Mannheim Corp.1996-10-30
VERDICT BARBITURATES (K963529)Editek, Inc.1996-10-30
VISUALINE COMBO V (COCAINE/THC) TEST (K963606)Sun Biomedical Laboratories, Inc.1996-10-30
VERDICT THC (K963516)Editek, Inc.1996-10-30
CEDIA N-ACETYLPROCAINAMIDE ASSAY (K963306)Boehringer Mannheim Corp.1996-10-29
ONTRAK TESTCUP AMPHETAMINES (K962411)Roche Diagnostic Systems, Inc.1996-10-07
ACETAMINOPHEN FLEX REAGENT CARTRIDGE (K963244)Dade Intl., Inc.1996-09-23
ON.SITE ALCOHOL (K963197)Ansys, Inc.1996-09-19
DRUG CALIBRATOR II (K962817)Dade Intl., Inc.1996-09-16
CARBAMAZEPINE FLEX REAGENT CARTRIDGE (K962820)Dade Intl., Inc.1996-09-13
GENTAMICIN FLEX REAGENT CARTRIDGE (K962819)Dade Intl., Inc.1996-09-13
TOBRAMYCIN FLEX REAGENT CARTRIDGE (K962818)Dade Intl., Inc.1996-09-13
VANCOMYCIN FLEX REAGENT CARTRIDGE (K963267)Dade Intl., Inc.1996-09-13
CEDIA ANTIBIOTIC TDM MULTI-CALS (K963191)Boehringer Mannheim Corp.1996-09-10
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