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Clinical Toxicology

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

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RecordFirmDate
MACRO-VUE CARD TEST, NETILMICIN (K821399)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-05-28
BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (K821347)Bioclinical Corp.1982-05-28
PHENOBARBITAL FLUORESCENT IMMUNO (K821408)American Diagnostic Corp.1982-05-24
STRATUS TDM CONTROL, LEVELS I,II,III (K820296)American Dade1982-05-14
KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME (K821154)Jay Rau, Technical Suppprt1982-05-13
TDX TM STREPTOMYCIN (K821136)Abbott Laboratories1982-05-13
THC-CANNABINOIDS DIRECT URINE RIA KIT (K820903)Immunalysis Corporation1982-05-05
ENZYMUNE-TEST DIGOXIN (K821000)Icl Scientific1982-04-26
COAT-A-COUNT AMIKACIN IRA (K820781)Diagnostic Products Corp.1982-04-09
EMIT-ST URINE COCAINE METABOLITE ASSAY (K820773)Syva Co.1982-04-08
SALICYLATES (K813431)Bio-Analytics Laboratories, Inc.1982-03-25
PROFILE GENERAL SET ASSAYED SERUM CONTR (K820468)General Diagnostics1982-03-25
EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO (K820440)Syva Co.1982-03-15
EMIT-ST URINE CALIBRATOR A (#3A319 (K820461)Syva Co.1982-03-11
EMIT-AMD AMIKACIN CONTROL (K820439)Syva Co.1982-03-11
EMIT-ST URINE CONTROLS SET A #3A349 (K820462)Syva Co.1982-03-11
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI (K820391)Hoffmann-La Roche, Inc.1982-03-08
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN (K820392)Ortho Diagnostic Systems, Inc.1982-03-04
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM (K820397)American Diagnostic Corp.1982-03-02
EMIT AND NETILMICIN CONTROL (K820323)Syva Co.1982-02-23
EMIT AND NETILMICIN ASSAY (K820324)Syva Co.1982-02-23
SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL (K820286)Syva Co.1982-02-23
DIGOXIN RADIOIMMUNOASSAY (K820274)American Diagnostic Corp.1982-02-23
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY (K820285)Syva Co.1982-02-18
CALIBRATOR SET (K820190)Syva Co.1982-02-12
CONTROL SET (K820191)Syva Co.1982-02-12
CARBAMAZEPINE ASSAY (K820189)Syva Co.1982-02-12
SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY (K820187)Syva Co.1982-02-12
PHENOBARBITAL ASSAY (K820188)Syva Co.1982-02-05
TDX DIGOXIN (K820154)Abbott Laboratories1982-02-05
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY (K820130)Syva Co.1982-02-05
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL (K820129)Syva Co.1982-01-29
PRIMIDONE REAGENT TEST KIT (K820138)Beckman Instruments, Inc.1982-01-28
TDX PRIMIDONE (K813597)Abbott Laboratories1982-01-22
AGGLUTEX AMPHETAMINE TEST KIT (K812986)Hoffmann-La Roche, Inc.1982-01-22
TOBRAMYCIN FLUORESCENT IMMUNOASSAY (K813542)American Diagnostic Corp.1982-01-12
AMIKACIN FLUORESCENT IMMUNOASSAY (K813541)American Diagnostic Corp.1982-01-12
PHENYTOIN FLUORESCENT IMMUNOASSAY (K813538)American Diagnostic Corp.1981-12-31
GENTAMICIN FLUORESCENT IMMUNOASSAY (K813539)American Diagnostic Corp.1981-12-31
AGGLUTEX BARBITURATES TEST KIT (K812988)Hoffmann-La Roche, Inc.1981-12-31
MRI TOBRAMYCIN RIA KIT (K813516)Microanalytic Research, Inc.1981-12-29
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL (K813349)Stanbio Laboratory1981-12-22
AGGLUTEX METHAQUALONE TEST KIT (K812987)Hoffmann-La Roche, Inc.1981-12-22
QAC CONTROL (K812950)The Quality Assurance Service Corp.1981-12-17
TDX VANCOMYCIN (K813218)Abbott Laboratories1981-12-08
EMIT-AAD THEOPHYLLINE CONTROL (K813241)Syva Co.1981-12-03
EMIT-AAD THEOPHYLLINE ASSAY (K813240)Syva Co.1981-12-03
SALICYLATE STAT-PAK (K813185)Clin Tech Diagnostics Corp.1981-11-24
ULTRA-DIG (K812749)Antibodies, Inc.1981-10-19
AMES TDA QUINIDINE TEST (K812753)Miles Laboratories, Inc.1981-10-19
AMES TDA THEOPHYLLINE TEST (K812518)Miles Laboratories, Inc.1981-09-23
KALLESTAD ANTISERA TO TOBRAMYCIN (K812415)Kallestad Laboratories, Inc.1981-09-09
MRI GENTAMICIN RIA KIT (K812394)Microanalytic Research, Inc.1981-09-08
EMIT-ST CANNABINOID CONTROLS (K812196)Syva Co.1981-08-20
EMIT-ST CANNABINOID ASSAY (K812195)Syva Co.1981-08-20
EMIT-ST CANNABINOID CALIBRATOR (K812197)Syva Co.1981-08-20
RUBELLA LATEX CARD TEST (K811637)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-08-13
COAT-A-COUNT DIGITOXIN RIA KIT (K812129)Diagnostic Products Corp.1981-08-13
ENDAB DIGOXIN KIT (K812054)Immunotech Corp.1981-08-12
KALLESTAD ANTISERA TO GENTAMICIN (K812050)Kallestad Laboratories, Inc.1981-08-03
A-GENT THEOPHYLLINE (K812003)Abbott Laboratories1981-07-27
COAT-A-COUNT DIGOXIN RIA (K811932)Diagnostic Products Corp.1981-07-23
DRUG STANDARDS (K811674)Supelco, Inc.1981-07-15
THERAPEUTIC DRUG CONTROL (K811756)Icl Scientific1981-07-15
AMES TDA CARBAMAZEPINE TEST (K811952)Miles Laboratories, Inc.1981-07-15
GENTAMICIN REAGENT TEST KIT (K811692)Beckman Instruments, Inc.1981-07-15
VIRGO IPA FOR DETECTION OF PHENYTOIN (K811745)Electro-Nucleonics Laboratories, Inc.1981-07-10
FLUOROMATIC THEOPHYLLINE FIA (K811856)Bio-Rad1981-07-10
EMIT-CAD PROCAINAMIDE ASSAY (K811770)Syva Co.1981-07-10
VIRGO IPA FOR DETECTION OF GENTAMICIN (K811744)Electro-Nucleonics Laboratories, Inc.1981-07-10
KALLESTAD QUANTICOAT 125 DIGOXIN (K811776)Kallestad Laboratories, Inc.1981-07-10
ANTI-ARRHYTHMIC CONTROL LEVELS I & II (K811809)Environmental Chemical Specialties1981-07-10
TDM ANTI-CONVULSANT CONTROL LEVELS I-II (K811811)Environmental Chemical Specialties1981-07-10
COAT-A-COUNT GENTAMICIN RIA KIT (K811844)Diagnostic Products Corp.1981-07-10
KALLESTAD ANTISERA TO PHENYTOIN (K811775)Kallestad Laboratories, Inc.1981-07-10
EMIT-TOX SERUM CALIBRATORS (K811620)Syva Co.1981-06-25
EMIT-ST SERUM PHENOBARBITAL ASSAY (K811621)Syva Co.1981-06-25
EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL (K811618)Syva Co.1981-06-25
EMIT-ST SERUM PHENOBARBITAL CONTROLS (K811619)Syva Co.1981-06-25
EMIT-ST SERUM PHENOBARBITAL CALIBRATOR (K811622)Syva Co.1981-06-25
EMIT-AND METHOTREXATE CONTROL (K811461)Syva Co.1981-06-09
EMIT-CAD QUINIDINE ASSAY (K811460)Syva Co.1981-06-09
EMIT-CAD QUINDINE CONTROL (K811462)Syva Co.1981-06-09
KALLESTAD ANTISERA TO PHENOBARBITAL (K811367)Kallestad Laboratories, Inc.1981-05-29
DIGOXIN (RIA) KIT (K811212)Immuno Assay Corp.1981-05-21
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY (K811034)Syva Co.1981-05-01
AMES TDA TM AMIKACIN TEST (K811026)Miles Laboratories, Inc.1981-04-29
AMES TDA TM PRIMIDONE TEST (K811007)Miles Laboratories, Inc.1981-04-29
BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M (K811067)Marion Laboratories, Inc.1981-04-29
AMES TDA TM PHENYTOIN TEST (K811025)Miles Laboratories, Inc.1981-04-29
AMES TDA TM PHENOBARBITAL TEST (K810994)Miles Laboratories, Inc.1981-04-29
DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (K810966)E. R. Squibb & Sons, Inc.1981-04-21
AMES TDA THEOPHYLLINE TEST (K810943)Miles Laboratories, Inc.1981-04-17
AMES TDA TOBRAMYCIN TEST (K810941)Miles Laboratories, Inc.1981-04-17
AMES TDA GENTAMICIN TEST (K810942)Miles Laboratories, Inc.1981-04-17
EMIT-ST SERUM BARBITURATE ASSAY (K810602)Syva Co.1981-04-03
MACRO-VUE CARD TEST (K810597)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-03-17
BECKMAN THEOPHYLLINE REAGENT TEST KIT (K810578)Beckman Instruments, Inc.1981-03-13
THERACHEM ANTI CONVULSANTA THEOPHYLLINE (K810504)Fisher Scientific Co., LLC1981-03-11
DCA DIGOX-SYN RIA TEST (K810477)Diagnostic Corp. of America1981-03-11
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