Atlas FDA

Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
OLYMPUS URINE PH (K905146)Diagnostic Systems1991-02-04
OPUS T3 TEST SYSTEM (K905410)Pb Diagnostic Systems, Inc.1991-02-04
IMMULITE (TM) TOTAL T3 (K905214)Cirrus Diagnostics, Inc.1991-02-01
KINETIC AMYLASE DETERMINATION (K905651)Biochemical Trade, Inc.1991-01-31
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 (K905661)Em Diagnostic Systems, Inc.1991-01-31
UBI MAGIWEL CORTISOL QUANTITATIVE (K905473)United Biotech, Inc.1991-01-31
IMMULITE HS-TSH (K905769)Cirrus Diagnostics, Inc.1991-01-31
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (K905649)Biochemical Trade, Inc.1991-01-30
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT (K905777)Immunotech Corp.1991-01-30
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS (K905829)Kamiya Biomedical Co.1991-01-30
DYNATECH MR4000 MICROPLATE READER (K904567)Dynatech Corp.1991-01-28
COULTER DART ALT (GPT) REAGENT (K905767)Coulter Electronics, Inc.1991-01-25
AIA-PACK HGH (K905757)Tosoh Medics, Inc.1991-01-25
QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM (K904603)Quantitative Medicine, Inc.1991-01-25
COLUMNS LIQUID CHROMATOGRAPHY DPM (K905538)Millpore Corp.1991-01-25
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 (K905660)Em Diagnostic Systems, Inc.1991-01-25
SEROZYME CORTISOL TEST KIT (K903975)Serono-Baker Diagnostics, Inc.1991-01-23
FLAGEN TRIIODOTHYRONINE (T3) ASSAY (K905656)Cyberfluor, Inc.1991-01-23
GEN-PROBE LUMINOMETER-LEADER 450 (K905762)Gen-Probe, Inc.1991-01-23
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II (K904989)Creative Laboratory Products, Inc.1991-01-23
IMX FREE TRIIODOTHYRONINE (K905261)Abbott Laboratories1991-01-23
ECLIPSE ICA TRIGLYCERIDES (K905601)Biotope, Inc.1991-01-17
DE-TOX TUBES A AND DE-TOX TUBES B (K904326)Dyna-Tek Industries1991-01-17
CREATINE KINASE UV REAGENT SET (K905588)Biochemical Trade, Inc.1991-01-17
SHBG IRMA KIT (K905247)Ventrex Laboratories, Inc.1991-01-17
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM (K904816)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-01-17
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 (K904468)Amresco, Inc.1991-01-17
ECLIPSE ICA BUN (K905602)Biotope, Inc.1991-01-16
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 (K905659)Em Diagnostic Systems, Inc.1991-01-15
TECHLYTE ELECTROLYTE ANALYZER (K905600)Technalysis, Inc.1991-01-15
CIBA CORNING ACS T4 IMMUNOASSAY (K905532)Ciba Corning Diagnostics Corp.1991-01-15
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM (K903733)Institute For Clinical Applications1991-01-15
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (K905215)Cirrus Diagnostics, Inc.1991-01-11
ECLIPSE ICA GLUCOSE (K905144)Biotope, Inc.1991-01-04
SYSTEMATE GGT (EPOS APPLICATION) #65414 (K905662)Em Diagnostic Systems, Inc.1991-01-04
ALKALINE PHOSPHATASE (K905684)Amresco, Inc.1990-12-28
MAGNESIUM REAGENT (K905544)Amresco, Inc.1990-12-27
AFFINITY FSH TEST SYSTEM (K905592)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-27
STATPAL BLOOD GAS MONITORING SYSTEM (K903965)Ppg Industries, Inc.1990-12-26
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST (K904082)Cholestech Corp.1990-12-26
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM (K904081)Heraeus Kulzer, Inc.1990-12-26
COULTER DIRECT BILLRUBIN REAGENT (K905622)Coulter Electronics, Inc.1990-12-26
CHEM-CHEX LIPID (K905389)Streck Laboratories, Inc.1990-12-26
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR (K904767)Analytical Control Systems, Inc.1990-12-26
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST (K903126)Crystal Diagnostics, Inc.1990-12-26
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL (K905296)Cholestech Corp.1990-12-26
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV (K905084)Reagents Applications, Inc.1990-12-20
RAICHEM GGT REAGENT (K905085)Reagents Applications, Inc.1990-12-20
KETOREX SANWA STANDARDS (K903365)Ihara Medics U.S., Inc.1990-12-20
CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL (K904781)Cholestrech Corp.1990-12-18
MICROZYME T3 ENZYME IMMUNOASSAY KIT (K904820)Immunotech Corp.1990-12-18
CHOLESTECH L.D.X. LEVEL 1 CONTROL (K904784)Cholestech Corp.1990-12-18
ELEGANCE TSH ELISA (K905099)Bioclone Australia Pty , Ltd.1990-12-18
LYTENING TM 6/R (K904726)Amdev, Inc.1990-12-18
COULTER CK-MB ISOENZYME REAGENT (K904866)Coulter Electronics, Inc.1990-12-13
ABL510 BLOOD GAS SYSTEM (K904513)Radiometer America, Inc.1990-12-13
DSL CK-MB (DSL #3200) (K904721)Diagnostic Systems Laboratories, Inc.1990-12-13
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (K905284)Amresco, Inc.1990-12-11
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 (K904004)Amresco, Inc.1990-12-11
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (K905226)Enzyme Technology, Inc.1990-12-11
HDL CHOLESTEROL CONTROL (K904872)Analytical Control Systems, Inc.1990-12-07
LDL-DIRECT CONTROLS (K902740)Isolab, Inc.1990-12-07
ELEGANCE GH ELISA (K905098)Bioclone Australia Pty , Ltd.1990-12-06
ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST (K904782)Carter Products1990-12-06
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL (K904829)Analytical Control Systems, Inc.1990-12-06
QCLYTE PROTEIN BASED ISE CONTROL (K904968)Baxter Healthcare Corp1990-12-06
CLINICAL CHEMISTRY CONTROL (K904075)Phoenix Diagnostics, Inc.1990-12-06
FLAGEN TM FREE T4 (K904539)Cyberfluor, Inc.1990-11-30
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT (K904184)Biotron U.S.A., Inc.1990-11-28
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 (K905096)Amresco, Inc.1990-11-28
SECONDARY CALIBRATORS (K904698)Bionostics, Inc.1990-11-28
CEDIA (R) VITAMIN B12/FOLATE ASSAY (K904776)Microgenics Corp.1990-11-20
KETONE TEST A SANWA STANDARD (K903367)Ihara Medics U.S., Inc.1990-11-20
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (K904660)Diagnostic Chemicals, Ltd. (Usa)1990-11-20
CIBA CORNING ACS FSH IMMUNOASSAY (K904649)Ciba Corning Diagnostics Corp.1990-11-20
P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT (K904761)Instrumentation Laboratory CO1990-11-20
KETONE TEST B SANWA STANDARD (K903366)Ihara Medics U.S., Inc.1990-11-20
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM (K904035)Helena Laboratories1990-11-09
KODATROL I AND II CONTROL AND DILUENT SET (K904768)Eastman Kodak Company1990-11-09
CIBA CORNING ACS PROLACTIN IMMUNOASSAY (K904714)Ciba Corning Diagnostics Corp.1990-11-07
BIOCLONES ELEGANCE LH ELISA KIT (K904387)Bioclone Australia Pty , Ltd.1990-11-06
REFLOTRON POTASSIUM TEST TABS (K904033)Boehringer Mannheim Corp.1990-11-06
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS (K903441)Intl. Immunoassay Laboratories, Inc.1990-11-06
ELEGANCE PROLACTIN ELISA (K904483)Bioclone Australia Pty , Ltd.1990-11-05
SERACON CR REFERENCE (K904503)Bhp Diagnostix, Inc.1990-11-02
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (K904666)Amersham Corp.1990-11-02
QUALICHECK 3 (K904733)Radiometer America, Inc.1990-11-02
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III (K904141)Medical Analysis Systems, Inc.1990-11-01
CLINICAL BLOOD GAS MIXTURES (K904163)Norco, Inc.1990-11-01
BIOCLONES ELEGANCE FSH ELISA KIT (K904405)Bioclone Australia Pty , Ltd.1990-10-26
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT (K903725)Immunotech Corp.1990-10-26
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS (K904099)Hichem Diagnostics1990-10-26
TARGET(TM) HOG ONE STEP (K903937)V-Tech, Inc.1990-10-22
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM (K904292)Boehringer Mannheim Corp.1990-10-22
SEROTONIN ENZYME IMMUNOASSAY (K903609)Immunotech Corp.1990-10-22
SYNCHRON CX 7 CLINICAL ANALYZER (K904219)Beckman1990-10-22
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (K903626)Beckman Instruments, Inc.1990-10-15
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) (K904100)Diagnostic Systems Laboratories, Inc.1990-10-15
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM (K904168)Boehringer Mannheim Corp.1990-10-15
MAXI TEST (K904016)Bhc Biotech , Ltd.1990-10-15
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