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Clinical Toxicology

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

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RecordFirmDate
EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT (K834550)Syva Co.1984-03-19
EMIT ST SERUM BENZODIAZEPINE ASSAY (K840236)Syva Co.1984-03-19
EMIT ST. URINE COCAINE METABOLITE (K834549)Syva Co.1984-03-19
SERALYZER THEOPHYLLINE REAGENT STRIPS (K832825)Miles Laboratories, Inc.1984-03-19
SERALYZER DRUG ASSAY CONTROL SERUM (K833977)Miles Laboratories, Inc.1984-03-19
SENSIBEAD EIA DIGOXIN KIT (K840673)Terumo Medical Corp.1984-03-12
MATCHED COMPONENT SET FOR DIGITOXIN (K834080)Cambridge Medical Technology1984-02-04
EMIT QST PHENYTOIN ASSAY (K834406)Syva Co.1984-02-03
TDX PROCAINAMIDE (K834464)Abbott Laboratories1984-02-03
LIQUI-SERA TDM CALIBRATORS (K834398)Biodiagnostic Intl1984-02-03
CHEMKIT PHENYTOIN DIAG. KIT (K833806)Abbott Laboratories1984-01-30
LIQUI-URA TOXIC URINE CONTROL (K834259)Biodiagnostic Intl1984-01-30
VENTREZYME THEOPHYLLINE IMMUNOASSAY (K833989)Vxr, Inc.1984-01-30
CHEM KIT PHENOBARBITAL (K833796)Abbott Laboratories1984-01-30
MODIF. OF EMIT URINE BARBITURATE (K833577)Syva Co.1984-01-26
MODIF. OF EMIT URINE CANNABINOID (K833580)Syva Co.1984-01-26
MODIF. OF EMIT URINE BENZODIAZEPINE (K833578)Syva Co.1984-01-26
MODIF. OF EMIT URINE AMPHETAMINE (K833579)Syva Co.1984-01-26
MODIF. OF EMIT URINE OPIATE ASSAY (K833581)Syva Co.1984-01-26
EMIT QST PHENOBARBITAL ASSAY (K834216)Syva Co.1984-01-24
PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (K833789)Medical & Scientific Designs, Inc.1984-01-24
URINE THC CANNABINOIDS DIRECT RIA KIT (K833911)Immunalysis Corporation1984-01-24
THEOFAST TEST KIT FOR QUANTITATIVE THEO (K834244)Allergenetics1984-01-24
LYPHOCHEK THERAPEUTIC DRUG CONTROL (K833794)Bio-Rad1984-01-24
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT (K834052)Abbott Laboratories1984-01-24
RIA COAT DIGOXIN (K833842)Immuno Assay Corp.1984-01-17
VENTREZYME DIGOXIN IMMUNOASSAY DIGOX (K833878)Vxr, Inc.1984-01-13
THERAPEUTIC DRUG CONTROL (K833761)Icl Scientific1984-01-13
SYVA ADVANCE DIGOXIN ASSAY (K833791)Syva Co.1984-01-12
DRUG STANDARDS (K833276)Supelco, Inc.1984-01-01
STRATUS THEOPHYLLINE ASSAY (K832965)American Dade1983-12-30
TEE ADAPTER 9890-FLUSH WINDING 282 (K833693)Shaban Mfg. Co.1983-12-30
LIDOAINE CALIBRATOR (K833380)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
PROCAINAMIDE CALIBRATOR (K833383)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL (K833378)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
LIDOCAINE ANALYTICAL TEST PACK ACA (K833379)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
VALPROIC ACID ANALYTICAL TEST PACK (K833381)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
VALPROIC ACID CALIBRATOR (K833382)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
PROCAINAMIDE ANALYTICAL TEST PACK (K833384)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
CHEM KIT THEOPHYLLINE DIAG. KIT (K833683)Abbott Laboratories1983-12-27
EMIT NETILMICIN ASSAY (K833715)Syva Co.1983-12-27
MODIFICATION OF EMIT AND AMIKACIN ASSAY (K833546)Syva Co.1983-12-08
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (K833623)Syva Co.1983-12-08
TOXI CHEM SERUM ALCOHOL CONTROL (K833514)Fisher Diagnostics1983-12-08
SERUM CHOLINESTERASE REAGENT SET (K833062)Sterling Biochemical, Inc.1983-11-25
GOLD FILM MERCURY ANALYZER #511 (K832933)Jerome Instrument Corp.1983-11-25
TDX THEOPHYLLINE (K833070)Abbott Laboratories1983-11-14
AMES TDA NETILMICIN TEST & SERUM (K832088)Miles Laboratories, Inc.1983-10-28
PARAMAX SALICYLATE REAGENT (K833003)American Dade1983-10-28
SONICAID MODEL D206E AIR EMBOLI-DETECT (K833227)Sonicaid, Inc.1983-10-27
BILE SALTS MIXTURE (K833211)Acumedia Manufacturers, Inc.1983-10-27
TOBRAMYCIN ANALYTICAL TEST PACK-ACA (K832985)E.I. Dupont DE Nemours & Co., Inc.1983-10-27
ACA TOBRAMYCIN CALIBRATOR (K832982)E.I. Dupont DE Nemours & Co., Inc.1983-10-27
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (K832799)Syva Co.1983-10-14
MOUTH-TO-MOUTH SHIELD APPLICATOR (K832590)Mem, Inc.1983-10-14
MODIFICA-OF EMIT AED PRIMIDONE ASSAY (K832798)Syva Co.1983-10-14
EMIT AED CARBAMAZEPINE ASSAY (K832720)Syva Co.1983-10-04
EMIT AED VALPROIC ACID ASSAY (K832719)Syva Co.1983-10-04
ACETAMINOPHER ASSAY KIT (K832045)Quantimetrix Corp.1983-10-04
HEPARIN COATED STAINLESS STEEL/TEFLON (K832030)Argon Medical Corp.1983-09-29
AMES TDA DISOPYRAMIDE TEST (K832766)Miles Laboratories, Inc.1983-09-29
CONTROL 282 (K832066)Bio-Nustics, Inc.1983-09-29
AMES TDA SISOMICIN TEST-CONTROL SERUM (K832792)Miles Laboratories, Inc.1983-09-29
MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY (K832797)Syva Co.1983-09-29
AMES TDA KANAMYCIN TEST-CONTROL SERUM (K832769)Miles Laboratories, Inc.1983-09-29
ACETAMINOPHEN(PARACETAMOL (K832567)Bio-Analytics Laboratories, Inc.1983-09-12
THEOPHYLLINE TEST PACK ACA (K831934)E.I. Dupont DE Nemours & Co., Inc.1983-09-12
A-GENT CARBAMAZEPINE (K832631)Abbott Laboratories1983-09-12
A-GENT PHENOBARBITAL (K832457)Abbott Laboratories1983-09-12
QUINIDINE FLUORESCENT IMMUNOASSAY (K832493)American Diagnostic Corp.1983-09-12
STRATUS CARBAMAZEPINE FLUROMETRIC (K832447)American Dade1983-09-12
EMIT CAD PROCAINAMIDE ASSAY (K832718)Syva Co.1983-09-12
A-GENT PHERYTOIN (K832419)Abbott Laboratories1983-09-01
CENTRAL VENOUS ACCESS CATHETER CVAC (K832396)Gish Biomedical, Inc.1983-08-31
STRATUS GENTAMICIN FLUOROMETRIC ENZYM (K832445)American Dade1983-08-31
STRATUS AMIKACIN FLUOROMETRIC (K832336)American Dade1983-08-31
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (K832408)American Dade1983-08-26
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS (K832098)Syva Co.1983-08-12
SOPHEIA DIGOXIN EIA KIT (K832163)Diagnostic Products Corp.1983-08-12
EMIT SERUM TRICYCLIC ANTIDEPRESSENT (K831978)Syva Co.1983-08-11
PHENOBARTIAL ASSAY USE ON COBAS-BIO (K832097)Syva Co.1983-08-11
EMIT AMD GENTAMICIN ASSAY (K832056)Syva Co.1983-08-08
EMIT CAD QUINIDINE ASSAY FOR USE W/ (K832096)Syva Co.1983-08-08
EMIT ASSAY AND TOBRAMYCIN (K832055)Syva Co.1983-08-08
EMIT AAD THEOPHYLLINE ASSAY (K832034)Syva Co.1983-08-01
EMIT AED PHENYTOIN ASSAY (K832033)Syva Co.1983-08-01
TRICYCLIC ANTIDEPRESSANTS (K831736)Utak Laboratories, Inc.1983-07-28
MAPROTILINE (K831735)Utak Laboratories, Inc.1983-07-26
AMOXAPINE 8-HYDRO-XYAMOXAPINE (K831734)Utak Laboratories, Inc.1983-07-26
CAFFINE TOXICOLOGY CONTROL (K831738)Utak Laboratories, Inc.1983-07-26
FLURAZEPAM TOXICOLOGY CONTROL (K831741)Utak Laboratories, Inc.1983-07-26
TRICYCLIC ANTIDEPRESSNATS VI (K831737)Utak Laboratories, Inc.1983-07-19
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO (K831979)Syva Co.1983-07-19
EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA (K831980)Syva Co.1983-07-19
THEOPHYLLINE ACA CALIBRATOR (K831933)E.I. Dupont DE Nemours & Co., Inc.1983-07-19
SALICYLATE ASSAY KIT (K831336)Quantimetrix Corp.1983-07-07
PENTOBARBITAL TOXICOLOGY CONTROL (K831739)Utak Laboratories, Inc.1983-07-06
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE (K831740)Utak Laboratories, Inc.1983-07-06
AMWA TDA THEOPHYLLINE TEST (K831514)Miles Laboratories, Inc.1983-06-30
TRI-LEVEL TDM CONTROL & I II III (K831500)Ortho Diagnostic Systems, Inc.1983-06-30
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