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Clinical Toxicology

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

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RecordFirmDate
EMIT-ST SERUM CONTROLS (K810468)Syva Co.1981-03-06
EMIT-ST SERUM ETHYL ALCOHOL ASSAY (K810467)Syva Co.1981-03-06
EMIT-ST SERUM CALBRATOR (K810464)Syva Co.1981-03-06
ETHYL ALCOHOL SERUM CALIBRATOR (K810466)Syva Co.1981-03-06
COPPER SULFATE SOLUTION SP. GR.1.053 (K803094)Accra Laboratories, Inc.1981-03-06
EMIT-ST SERUM BENZODIAZEPINE ASSAY (K810463)Syva Co.1981-03-06
EMIT-ST ETHYL ALCOHOL SERUM CONTROLS (K810465)Syva Co.1981-03-06
DIGOXIN RIA ASSAY (K810296)Ria Diagnostics1981-02-19
ACETAMINOPHEN/SALICYLATE CONTROL (K810235)Clin Tech Diagnostics Corp.1981-02-10
TOXICOLOGY CONTROL (K810201)Utak Laboratories, Inc.1981-02-04
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S (K810078)Hyland Therapeutic Div., Travenol Laboratories1981-02-02
CYBREX VALPROIC ACID (K803236)Abbott Laboratories1981-01-28
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. (K810077)Hyland Therapeutic Div., Travenol Laboratories1981-01-28
GAMMA STICK 125-1 TOBRAMYCIN RIA KIT (K810011)Alpha Gamma Laboratory1981-01-28
PROFILE CARDIAC SET ASSAYED SERUM CONTR. (K803036)General Diagnostics1980-12-22
DIGOXIN & PHENYTOIN CONTROL SERA (K803097)Amersham Corp.1980-12-22
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (K803045)American Dade1980-12-22
I-125 LABELED DIGOXIN (K803047)Pcl-Ria, Inc.1980-12-22
DIGOXIN RIABEAD DIAGNOSTIC KIT (K803075)Abbott Laboratories1980-12-22
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. (K803039)General Diagnostics1980-12-22
AMES TDA AMIKACIN CONTROL SERUM (K803107)Miles Laboratories, Inc.1980-12-22
AMIKACIN RIA KIT (K802877)Antibodies, Inc.1980-12-19
CYBREX CARBAMAZEPINE (K802902)Abbott Laboratories1980-12-19
DIGOXIN RADIOIMMUNOASSAY KIT (K802841)American Diagnostic Corp.1980-12-18
BECKMAN ICS DRUG CONTROL SERA (K802854)Beckman Instruments, Inc.1980-12-11
PERICARDIOCENTESIS KIT (K802289)Stanco Medical, Inc.1980-11-26
CYBREX TOBRAMYCIN (K802668)Abbott Laboratories1980-11-24
IN VITRO DIAGNOSTIC STANDARDS (K802278)Supelco, Inc.1980-11-24
CARDIOACTIVE DRUGS CONTROL (K802672)Fisher Scientific Co., LLC1980-11-24
AMES TDA PRIMIDONE TEST (K802654)Miles Laboratories, Inc.1980-11-12
CYBREX AMIKACIN (K802669)Abbott Laboratories1980-11-12
EMIT-STM AMPHETAMINE ASSAY (K802623)Syva Co.1980-11-12
EMIT-STM URINE CALIBRATORS (K802624)Syva Co.1980-11-12
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (K802620)Syva Co.1980-10-31
EMIT-STM ETHYL ALCOHOL ASSAY (K802621)Syva Co.1980-10-31
EMIT-STM OPIATE ASSAY (K802615)Syva Co.1980-10-31
EMIT-STM BARBITURATE ASSAY (K802617)Syva Co.1980-10-31
EMIT-STM BENZODIAZEPINE ASSAY (K802616)Syva Co.1980-10-31
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT (K802461)Immunotech Corp.1980-10-31
CYBREX LIDOCAINE (K802131)Abbott Laboratories1980-10-31
EMIT-STM ETHYL ALCOHOL URINE CONTROLS (K802618)Syva Co.1980-10-31
PHENYTOIN REAGENT TEST KIT (K802038)Beckman Instruments, Inc.1980-10-23
PHENOBARBITAL REAGENT TEST KIT (K802039)Beckman Instruments, Inc.1980-10-23
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY (K802066)Immunotech Corp.1980-10-23
OREIA-Q-DIG (K802358)Organon, Inc.1980-10-10
7 TRICYCLIC ANTIDE PRESSANTS (K802245)Technicon Instruments Corp.1980-10-10
AMES TDA PHENOBARBITAL TEST (K802255)Miles Laboratories, Inc.1980-09-26
FIAX TEST KIT FOR THEOPHYLLINE QUANT. (K801642)Intl. Diagnostic Technology1980-08-27
DISPOSABLE MEDICATION NEBULIZER (K801867)Hospitax1980-08-20
AMES TDA TM PHENYTOIN TEST (K801736)Miles Laboratories, Inc.1980-08-20
HI-M-TEST FOR METHADONE TEST #2 (K801509)Technam, Inc.1980-07-14
DIGOXIN EIA KIT (K801490)M.A. Bioproducts1980-07-14
APPLICATION OF EMIT THEOPHYLLINE ASSAY (K801476)Syva Co.1980-07-08
AMERLEX DIGOXIN RIA KIT (K801413)Amersham Corp.1980-07-08
EMIT VALPROIC ACID ASSAY (K801207)Syva Co.1980-06-20
STANBIO ACETAMINOPHEN TEST SET #0850 (K801014)Stanbio Laboratory1980-06-20
DUPONT PREP APPLI. FOR PHENOBARBITAL, (K801276)E.I. Dupont DE Nemours & Co., Inc.1980-06-20
DIGOXIN RADIOIMMUNOASSAY KIT (K801202)Technia Diagnostics , Ltd.1980-06-20
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA (K801308)Intl. Diagnostic Technology1980-06-20
EMIT VALPROIC ACID CONTROL (K801206)Syva Co.1980-06-17
EMIT DISOPYRAMIDE CONTROL (K801205)Syva Co.1980-06-09
EMIT DISOPYRAMIDE ASSAY (K801204)Syva Co.1980-06-09
AMES TDA AMIKACIN (K801130)Miles Laboratories, Inc.1980-05-28
CYBREX GENTAMICIN (K801084)Abbott Laboratories1980-05-23
DIGOXIN CLASP RIA KIT (K800997)E. R. Squibb & Sons, Inc.1980-05-08
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL (K800888)Utak Laboratories, Inc.1980-05-02
ANTICONVULSANTS TOXICOLOGY CONTROL (K800882)Utak Laboratories, Inc.1980-04-29
CARDIACS II TOXICOLOGY CONTROL (K800884)Utak Laboratories, Inc.1980-04-29
BARBITURATES TOXICOLOGY CONTROL (K800885)Utak Laboratories, Inc.1980-04-29
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL (K800886)Utak Laboratories, Inc.1980-04-29
HYPNOTICS PLUS SALICYLATE TX CONTROL (K800887)Utak Laboratories, Inc.1980-04-29
CARDIACS I TOXICOLOGY CONTROL (K800883)Utak Laboratories, Inc.1980-04-29
TRICYCLIC ANTIDEPRESSANT II TX CONTROL (K800889)Utak Laboratories, Inc.1980-04-29
DIGOCTK 125 (K800773)Sorin Biomedica, Fiat, USA, Inc.1980-04-24
GAMMA STICK GENTAMICIN RIA KIT (K800537)Alpha Gamma Laboratory1980-04-24
TOBRAMYCIN RIA KIT (K800743)Antibodies, Inc.1980-04-16
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (K800357)Ortho Diagnostics, Inc.1980-04-16
AMES TDA THEOPHYL-LINE TEST (K800646)Miles Laboratories, Inc.1980-04-10
TOBRAM E.R.A. TM (K800517)P-L Biochemicals, Inc.1980-03-20
RIA PHASE DIGOXIN (K800205)Boehringer Mannheim Corp.1980-03-19
ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 (K800364)Hoffrel Instruments, Inc.1980-03-12
DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG (K792282)California Medical Developments, Inc.1980-02-29
EMIT -D.A.U. CANNABINOID URINE CALIBS. (K800247)Syva Co.1980-02-26
EMIT -D.A.U. CANNABINOID URINE ASSAY (K800246)Syva Co.1980-02-26
THEOPHYLLINE RIASSAY (K792062)Ria Diagnostics1980-02-25
EMIT TOBRAMYCIN ASSAY (K800150)Syva Co.1980-02-05
INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS (K792469)Intersci Corp.1980-01-23
FIAX TEST KIT FOR GENTAMICIN QUAN. (K800032)Intl. Diagnostic Technology1980-01-23
FLUOROMATIC PHENOLBARBITAL FIA (K800090)Bio-Rad1980-01-23
LITHIUM DILUENT (1500 MM/E) (K800039)Gilford Diagnostics1980-01-21
ELVI-AMINOLEVULINIC ACID (K792407)Volu Sol Medical Industries1980-01-16
FLUOROMATIC PHENYTOIN FIA (K792640)Bio-Rad1980-01-11
ACA ETHOSURIMIDE TEST PACK (K792584)E.I. Dupont DE Nemours & Co., Inc.1979-12-31
GENTAMICIN LIQUID CONTROL SERUM (K792262)Hemometrix1979-12-18
GENTAMICIN CONTROL SERUM (K792261)Hemometrix1979-12-18
TOBRAMYCIN CONTROL SERUM (K792263)Hemometrix1979-12-18
TOBRAMYCIN LIQUID CONTROL SERUM (K792264)Hemometrix1979-12-18
AMIKACIN CONTROL SERUM (K792259)Hemometrix1979-12-18
AMIKACIN LIQUID CONTROL SERUM (K792260)Hemometrix1979-12-18
HIM TEST COCAINE (K792429)Tecknam, Inc.1979-12-07
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