meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1991-02-22

Clearances · page 66 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K910256 ECLIPSE ICA TSH Biotope, Inc. JLW Class II 1991-02-22
K905790 TOTAL PROTEIN REAGENT SET Biochemical Trade, Inc. CEK Class II 1991-02-21
K905710 PHARMACIA DELFIA NEONATAL HTSH KIT Pharmacia, Inc. JLW Class II 1991-02-21
K905650 KINETIC ALKALINE PHOSPHATASE DETERMINATION Biochemical Trade, Inc. CJE Class II 1991-02-13
K905477 OLYMPUS URINE PH CALIBRATORS LEVELS I AND II Em Diagnostic Systems, Inc. JIS Class II 1991-02-13
K910249 STRATUS ESTRADIOL FLUOREMETRIC ENZYME Baxter Healthcare Corp CHP Class I 1991-02-13
K905742 CLEARBLUE EASY Unipath , Ltd. LCX Class II 1991-02-13
K905619 CREATININE (RATE) REAGENT SET Biochemical Trade, Inc. CGX Class II 1991-02-13
K905861 ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH E.I. Dupont DE Nemours & Co., Inc. CFE Class II 1991-02-06
K905280 BIOTROL BILIRUBIN C & T CONTROL Biotrol, USA, Inc. JJX Class I 1991-02-04
K905410 OPUS T3 TEST SYSTEM Pb Diagnostic Systems, Inc. CDP Class II 1991-02-04
K905146 OLYMPUS URINE PH Diagnostic Systems JQY Class I 1991-02-04
K910140 ELECTRAPETTE (R) Matrix Technologies Corp. JQW Class I 1991-02-04
K905814 LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY London Diagnostics, Inc. CGJ Class I 1991-02-04
K910198 CIBA CORNING ACS LH IMMUNOASSAY Ciba Corning Diagnostics Corp. CEP Class I 1991-02-04
K910143 KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) Eastman Kodak Company JIY Class I 1991-02-04
K905214 IMMULITE (TM) TOTAL T3 Cirrus Diagnostics, Inc. CDP Class II 1991-02-01
K905769 IMMULITE HS-TSH Cirrus Diagnostics, Inc. JLW Class II 1991-01-31
K905473 UBI MAGIWEL CORTISOL QUANTITATIVE United Biotech, Inc. CGR Class II 1991-01-31
K905661 SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 Em Diagnostic Systems, Inc. CEK Class II 1991-01-31
K905651 KINETIC AMYLASE DETERMINATION Biochemical Trade, Inc. JFJ Class II 1991-01-31
K905829 DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS Kamiya Biomedical Co. CEL Class I 1991-01-30
K905649 GAMMA-GLUTAMYL TRANSFERASE DETERMINATION Biochemical Trade, Inc. JQB Class I 1991-01-30
K905777 MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT Immunotech Corp. CEE Class II 1991-01-30
K904567 DYNATECH MR4000 MICROPLATE READER Dynatech Corp. JJQ Class I 1991-01-28
K904603 QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM Quantitative Medicine, Inc. CEK Class II 1991-01-25
K905660 SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 Em Diagnostic Systems, Inc. CIX Class II 1991-01-25
K905538 COLUMNS LIQUID CHROMATOGRAPHY DPM Millpore Corp. KZR Class I 1991-01-25
K905757 AIA-PACK HGH Tosoh Medics, Inc. CFL Class I 1991-01-25
K905767 COULTER DART ALT (GPT) REAGENT Coulter Electronics, Inc. CKA Class I 1991-01-25
K905261 IMX FREE TRIIODOTHYRONINE Abbott Laboratories CDP Class II 1991-01-23
K905656 FLAGEN TRIIODOTHYRONINE (T3) ASSAY Cyberfluor, Inc. CDP Class II 1991-01-23
K905762 GEN-PROBE LUMINOMETER-LEADER 450 Gen-Probe, Inc. JJQ Class I 1991-01-23
K904989 CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II Creative Laboratory Products, Inc. JJY Class I 1991-01-23
K903975 SEROZYME CORTISOL TEST KIT Serono-Baker Diagnostics, Inc. CGR Class II 1991-01-23
K905588 CREATINE KINASE UV REAGENT SET Biochemical Trade, Inc. JHW Class II 1991-01-17
K904468 DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 Amresco, Inc. CIG Class II 1991-01-17
K904326 DE-TOX TUBES A AND DE-TOX TUBES B Dyna-Tek Industries DPA Class I 1991-01-17
K904816 THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM Bd Becton Dickinson Vacutainer Systems Preanalytic CDX Class II 1991-01-17
K905247 SHBG IRMA KIT Ventrex Laboratories, Inc. CDZ Class I 1991-01-17
K905601 ECLIPSE ICA TRIGLYCERIDES Biotope, Inc. CDT Class I 1991-01-17
K905602 ECLIPSE ICA BUN Biotope, Inc. CDQ Class II 1991-01-16
K905659 SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 Em Diagnostic Systems, Inc. CIC Class II 1991-01-15
K905600 TECHLYTE ELECTROLYTE ANALYZER Technalysis, Inc. JGS Class II 1991-01-15
K903733 ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM Institute For Clinical Applications LBR Class I 1991-01-15
K905532 CIBA CORNING ACS T4 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDX Class II 1991-01-15
K905215 IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER Cirrus Diagnostics, Inc. JJQ Class I 1991-01-11
K905144 ECLIPSE ICA GLUCOSE Biotope, Inc. CFR Class II 1991-01-04
K905662 SYSTEMATE GGT (EPOS APPLICATION) #65414 Em Diagnostic Systems, Inc. JQB Class I 1991-01-04
K905684 ALKALINE PHOSPHATASE Amresco, Inc. CJE Class II 1990-12-28
K905544 MAGNESIUM REAGENT Amresco, Inc. JGJ Class I 1990-12-27
K905592 AFFINITY FSH TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CGJ Class I 1990-12-27
K905622 COULTER DIRECT BILLRUBIN REAGENT Coulter Electronics, Inc. CIG Class II 1990-12-26
K905296 CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL Cholestech Corp. LBS Class I 1990-12-26
K903126 CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST Crystal Diagnostics, Inc. CHH Class I 1990-12-26
K904081 GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM Heraeus Kulzer, Inc. CGA Class II 1990-12-26
K904082 CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST Cholestech Corp. CGA Class II 1990-12-26
K905389 CHEM-CHEX LIPID Streck Laboratories, Inc. JJY Class I 1990-12-26
K904767 ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR Analytical Control Systems, Inc. JIX Class II 1990-12-26
K903965 STATPAL BLOOD GAS MONITORING SYSTEM Ppg Industries, Inc. CHL Class II 1990-12-26
K903365 KETOREX SANWA STANDARDS Ihara Medics U.S., Inc. JIN Class I 1990-12-20
K905085 RAICHEM GGT REAGENT Reagents Applications, Inc. JQB Class I 1990-12-20
K905084 RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV Reagents Applications, Inc. CGS Class II 1990-12-20
K904726 LYTENING TM 6/R Amdev, Inc. JFP Class II 1990-12-18
K904781 CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL Cholestrech Corp. JJY Class I 1990-12-18
K904820 MICROZYME T3 ENZYME IMMUNOASSAY KIT Immunotech Corp. CDP Class II 1990-12-18
K905099 ELEGANCE TSH ELISA Bioclone Australia Pty , Ltd. JLW Class II 1990-12-18
K904784 CHOLESTECH L.D.X. LEVEL 1 CONTROL Cholestech Corp. JJY Class I 1990-12-18
K904866 COULTER CK-MB ISOENZYME REAGENT Coulter Electronics, Inc. JHT Class II 1990-12-13
K904721 DSL CK-MB (DSL #3200) Diagnostic Systems Laboratories, Inc. JHT Class II 1990-12-13
K904513 ABL510 BLOOD GAS SYSTEM Radiometer America, Inc. CHL Class II 1990-12-13
K904004 AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 Amresco, Inc. CGS Class II 1990-12-11
K905284 HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 Amresco, Inc. LBR Class I 1990-12-11
K905226 TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL Enzyme Technology, Inc. JGY Class I 1990-12-11
K904872 HDL CHOLESTEROL CONTROL Analytical Control Systems, Inc. JJY Class I 1990-12-07
K902740 LDL-DIRECT CONTROLS Isolab, Inc. JJY Class I 1990-12-07
K904968 QCLYTE PROTEIN BASED ISE CONTROL Baxter Healthcare Corp JJY Class I 1990-12-06
K904829 ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL Analytical Control Systems, Inc. JJY Class I 1990-12-06
K905098 ELEGANCE GH ELISA Bioclone Australia Pty , Ltd. CFL Class I 1990-12-06
K904075 CLINICAL CHEMISTRY CONTROL Phoenix Diagnostics, Inc. JJY Class I 1990-12-06
K904782 ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST Carter Products LCX Class II 1990-12-06
K904539 FLAGEN TM FREE T4 Cyberfluor, Inc. CEC Class II 1990-11-30
K905096 GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 Amresco, Inc. JQB Class I 1990-11-28
K904184 BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT Biotron U.S.A., Inc. LBR Class I 1990-11-28
K904698 SECONDARY CALIBRATORS Bionostics, Inc. JIT Class II 1990-11-28
K904649 CIBA CORNING ACS FSH IMMUNOASSAY Ciba Corning Diagnostics Corp. CGJ Class I 1990-11-20
K904776 CEDIA (R) VITAMIN B12/FOLATE ASSAY Microgenics Corp. CDD Class II 1990-11-20
K903366 KETONE TEST B SANWA STANDARD Ihara Medics U.S., Inc. JIN Class I 1990-11-20
K903367 KETONE TEST A SANWA STANDARD Ihara Medics U.S., Inc. JIN Class I 1990-11-20
K904660 ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 Diagnostic Chemicals, Ltd. (Usa) JFM Class II 1990-11-20
K904761 P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT Instrumentation Laboratory CO CIE Class II 1990-11-20
K904035 REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM Helena Laboratories LBT Class I 1990-11-09
K904768 KODATROL I AND II CONTROL AND DILUENT SET Eastman Kodak Company JJY Class I 1990-11-09
K904714 CIBA CORNING ACS PROLACTIN IMMUNOASSAY Ciba Corning Diagnostics Corp. CFT Class I 1990-11-07
K903441 MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS Intl. Immunoassay Laboratories, Inc. JHX Class II 1990-11-06
K904387 BIOCLONES ELEGANCE LH ELISA KIT Bioclone Australia Pty , Ltd. CEP Class I 1990-11-06
K904033 REFLOTRON POTASSIUM TEST TABS Boehringer Mannheim Corp. CEJ Class II 1990-11-06
K904483 ELEGANCE PROLACTIN ELISA Bioclone Australia Pty , Ltd. CFT Class I 1990-11-05
K904733 QUALICHECK 3 Radiometer America, Inc. JJS Class I 1990-11-02
K904666 AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 Amersham Corp. JLW Class II 1990-11-02

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.