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Clinical Toxicology

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

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RecordFirmDate
EMIT-BARBITURATE ASSAY (K792114)Syva Co.1979-12-04
TECHNICON FAST-LC SYS. ANTICONVU DRUGS (K791979)Technicon Instruments Corp.1979-11-13
DIGOXIN RADIOIMMUNOASSAY SYSTEM (K792153)Radioimmunoassay, Inc.1979-11-13
HI-M-TEST MORPHINE (K791551)Technam, Inc.1979-10-17
QUANTIMUNE GENTAMICIN RIA GENTAMICIN (K791770)Bio-Rad1979-10-17
CHOLINESTERASE REAGENT (K791725)Gilford Diagnostics1979-10-17
CENTRIA PHENYTOIN RIA TEST SET (K791896)Ventrex Laboratories, Inc.1979-10-17
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY (K791596)Bio-Rad1979-10-17
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (K791547)Bio-Rad1979-10-12
TETRAHYDROCANNALBINOL DIRECT BLOOD KIT (K791649)Immunalysis Corporation1979-10-11
TECHNICON STAR SYSTEM (K791549)Technicon Instruments Corp.1979-09-27
QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO (K791502)Bio-Rad1979-09-04
BIOASSAY SYSTEM, MS-2 SERUM (K782049)Abbott Laboratories1979-08-28
AMES TDA/TOBRAMYCIN (K791435)Miles Laboratories, Inc.1979-08-16
AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM (K791325)Micromedic Systems1979-08-16
VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT (K791355)Ventrex Laboratories, Inc.1979-08-10
RIA, DIGNXIN-125-I (K790602)Endocrine-Metabolic Center1979-07-30
RF CONTROLS (K790986)Wampole Laboratories1979-06-28
EMIT AUTO DIGOXIN ASSAY (K790937)Syva Co.1979-06-15
EMIT-D.A.U. PHENCYCLIDINE URINE LOW (K790398)Syva Co.1979-06-15
AMES TDA/GENTGMICIN (K790584)Miles Laboratories, Inc.1979-06-15
URINE MEDIUM CALIBRATOR (K790399)Syva Co.1979-06-15
URINE NEGATIVE CALIBRATOR (K790400)Syva Co.1979-06-15
DRUG ABUSE DIPSTICKS (K790805)Technical Resources, Inc.1979-06-06
BACTEC (K790899)Bd Becton Dickinson Vacutainer Systems Preanalytic1979-05-23
EMIT GENTAMICIN CONTROL (K790830)Syva Co.1979-05-15
EMIT GENTAMICIN ASSAY (K790829)Syva Co.1979-05-15
EMIT-TOX SERUM CALIBRATORS (K790735)Syva Co.1979-05-03
EMIT-TOX SERUM BENZODIAZEPINE ASSAY (K790736)Syva Co.1979-04-26
RIA TEST KIT, CENTRIA DIGOXIN (K790540)Ventrex Laboratories, Inc.1979-04-23
OREIA - DIGOXIN (K790521)Organon, Inc.1979-04-10
EMIT QUINIDINE ASSAY (K790403)Syva Co.1979-03-21
EMIT AUTO DIGOXIN ASSAY (K790303)Syva Co.1979-03-19
EMIT-QUINIDINE CONTROL (K790402)Syva Co.1979-03-15
EMIT AED ASSAYS 3500 COMPUTER DIRECTED (K790255)Syva Co.1979-03-02
EMIT THEOPHYLLINE ASSAY (K790256)Syva Co.1979-03-02
THERA CHEM (K782128)Fisher Scientific Co., LLC1979-03-02
RIA KIT, SISOMICIN (K782126)Diagnostic Products Corp.1979-02-15
GENTAMICIN FLUROIMMUNASSAY KIT (K782025)Technia Diagnostics , Ltd.1979-01-26
LIDOCAINE CALIBRATOR KIT (K780731)Vitek Systems, Inc.1979-01-17
RIA KIT, KANAMYCIN (K782125)Diagnostic Products Corp.1979-01-10
ANALYTICAL TEST PACK, CARBAMAZEPINE (K781958)E.I. Dupont DE Nemours & Co., Inc.1979-01-10
EMIT PROCAINAMIDE CONTROL SET (K782084)Syva Co.1979-01-10
ANALYTICAL TEST PACK, PRIMIDONE (K781957)E.I. Dupont DE Nemours & Co., Inc.1979-01-10
ANALYSIS SYSTEM, PREP SAMPLE (K781941)E.I. Dupont DE Nemours & Co., Inc.1979-01-03
TEST SET, 125 I-DIGOXIN (K781834)Wien Laboratories, Inc.1979-01-03
CONTROL SET, EMIT METHOTREXATE (K781827)Syva Co.1979-01-03
THEOPHYLLINE CONTROL SERUM (K780961)Vitek Systems, Inc.1978-12-07
SERUM, CONTROL, DRUGS, ANTIARRYTHMIC (K780960)Vitek Systems, Inc.1978-12-07
PROCAINAMIDE CALIBRATOR KIT (K780732)Vitek Systems, Inc.1978-11-22
MACRO-VUE TEST, GENTAMICIN (K781674)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-11-15
RIA, DIGOXIN (K781660)E. R. Squibb & Sons, Inc.1978-10-24
DIALYSIS SYS., PDS 400 & RO 400 (K781156)Physio-Control Corp.1978-10-24
KIDNEY, ARTIFICIAL (K781153)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-10-17
EMIT PROCAINAMIDE ASSAY (K781382)Syva Co.1978-10-17
EMIT N-ACETYLPROCAINAMIDE ASSAY (K781378)Syva Co.1978-10-10
THC DIRECT RIA KIT (K781048)Immunalysis Corporation1978-10-03
RIANEN ASSAY SYSTEM, 125I KIT (K781495)New England Nuclear1978-09-14
CUTTER RESIFLEX FOLEY CATHETERS (K781140)Cutler Laboratories, Inc.1978-09-07
KIDNEY, ARTIFICIAL, C-DAK 2.0 (K781237)Cordis Corp.1978-08-31
KIDNEY, ARTIFICIAL, C-DAK 1.5 (K781238)Cordis Corp.1978-08-31
DIGOXIN RIA (PEG) KIT (K781335)Ortho Diagnostics, Inc.1978-08-31
BANDAGE, COMPRESSION, FISTULAID (K781110)Medical Device Laboratories1978-08-18
A-V FISTULA NEEDLE (K781331)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-08-17
BIO-MONITOR TOBRAMYCIN (K780950)Monitor Science Corp.1978-08-14
BIO-MONITOR AMIKACIN (K780949)Monitor Science Corp.1978-08-14
IN VITRO TOBRAMYCIN RIA KIT (K780934)Clinical Assays, Inc.1978-08-14
DIGOXIN STANDARDS IN HUMAN SERUM (K780889)Pcl-Ria, Inc.1978-08-14
BIO-MONITOR GENTAMICIN (K780951)Monitor Science Corp.1978-08-14
(125 I) DIGITOXIN RIA KIT (K780766)Diagnostic Products Corp.1978-07-27
MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS (K781010)The Perkin-Elmer Corp.1978-07-27
HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (K780652)The London Co.1978-07-27
ANTICONVULSANTS II CALIBRATOR KIT (K780734)Vitek Systems, Inc.1978-06-22
ANTICONVULSANTS III CALIBRATOR KIT (K780733)Vitek Systems, Inc.1978-06-22
GENTAMICIN RIA KIT (K780516)Antibodies, Inc.1978-04-28
AMINOGLYCOSIDE TEST SYSTEM (K772116)Nichols Institute Diagnostics1978-04-28
EMIT CARBAMAZEPINE ASSAY (K780466)Syva Co.1978-04-24
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT (K780475)Burroughs Wellcome Co.1978-04-24
THEOPHYLLINE ASSAY TO THE GEMSAEC (K780442)Syva Co.1978-04-12
ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (K780461)Syva Co.1978-04-12
THEOPHYLLINE ASSAY TO THE CENTRIFICHEM (K780441)Syva Co.1978-04-12
ANALYZER, FAST, CENTRIFUGAL, GEMSAEC (K780380)Syva Co.1978-04-12
AMIKACIN (K780494)Diagnostic Products Corp.1978-04-10
DIGITOXIN (K780495)Diagnostic Products Corp.1978-04-10
CBR-DIGOXIN ANTISERUM (K780498)Clinical Bioresearch1978-04-05
IN VITRO THEOPHYLLINE RIA TEST (K772017)Clinical Assays, Inc.1978-03-27
QUANTITOPE 125-I GENTAMICIN RIA KIT (K780323)Kallestad Laboratories, Inc.1978-03-17
RABBIT ANTIBODY TO DIGOXIN (K780316)Pcl-Ria, Inc.1978-03-17
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE (K780218)Syva Co.1978-03-03
RIALYZE DIGOXIN (K780075)Miles Laboratories, Inc.1978-02-28
LIQUISOL DIGOXIN RIA TEST KIT (K780207)Damon Corp.1978-02-23
TOBRAMYCIN 125I RIA KIT (K780182)New England Nuclear1978-02-13
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA (K772422)Bio-Rad1978-02-13
ANTICONVULSANT CONTROL SERUM (K780142)Mcdonnell Douglas Corp.1978-02-03
AMINOGLYCOSIDE TEST SYSTEM (K780048)Nichols Institute Diagnostics1978-01-20
KANAMYCIN RIA (K772038)Monitor Science Corp.1978-01-12
RIANEN GENTAMICIN RIA KIT (K772425)New England Nuclear1978-01-05
125I DIGOXIN TEST SET (K772306)Wien Laboratories, Inc.1977-12-22
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS (K772098)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-12-20
EMIT ANTIEPILEPTIC DRUG ASSAYS (K772179)Syva Co.1977-12-20
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