meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1992-04-22

Clearances · page 62 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K915689 SLT SPECTRA Slt Labinstruments, Inc. JJQ Class I 1992-04-22
K915690 SLT 340 ATTC Slt Labinstruments, Inc. JJQ Class I 1992-04-22
K913380 MYDAS(TM)-MB2/MYDAS(TM)-MB Intl. Immunoassay Laboratories, Inc. JHX Class II 1992-04-22
K920809 KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD King Diagnostics, Inc. JIS Class II 1992-04-17
K920766 T4 EIA BEAD ASSAY Tech-Co, Inc. CDX Class II 1992-04-17
K920940 AMERLITE FREE THYROID CONTROL SERA LAN.4002 Eastman Kodak Company JJY Class I 1992-04-17
K915770 ULTRA+ BLOOD GLUCOSE TEST STRIP Home Diagnostics, Inc. CGA Class II 1992-04-14
K915772 DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP Home Diagnostics, Inc. CGA Class II 1992-04-14
K920920 ELISA TUBE LH TEST KIT Bio Clinic Co. CEP Class I 1992-04-08
K920921 ELISA TUBE PROLACTIN TEST KIT Bio Clinic Co. CFT Class I 1992-04-08
K921176 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Vitek Systems, Inc. CEP Class I 1992-04-08
K921012 PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG Bd Becton Dickinson Vacutainer Systems Preanalytic LCX Class II 1992-04-08
K920826 HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL Eastman Kodak Company JJY Class I 1992-04-07
K920918 TMB CHROMOGEN/SUBSTRATE REAGENT SET Bio Clinic Co. JHI Class II 1992-04-07
K920712 MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. KLI Class II 1992-03-27
K915814 SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS Sirchie Finger Print Laboratories, Inc. JKA Class II 1992-03-27
K921057 AMYLASE REAGENT Genzyme Corp. JFJ Class II 1992-03-27
K920917 ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY Bio Clinic Co. CGJ Class I 1992-03-26
K920856 VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS Hycor Biomedical, Inc. JLW Class II 1992-03-26
K920716 DIRECT PREGNANCY TEST Tech-Co, Inc. JHJ Class II 1992-03-24
K921087 CHEMSTRIP URINE ANALYZER Boehringer Mannheim Corp. KQO Class I 1992-03-24
K920335 MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD Heraeus Kulzer, Inc. CKA Class I 1992-03-24
K920505 AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR Eastman Kodak Company JHI Class II 1992-03-23
K920576 AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL Eastman Kodak Company CGI Class I 1992-03-23
K920914 MP/S SINGLE WAVELENGTH MINI PHOTOMETER Artel, Inc. JJQ Class I 1992-03-23
K921025 SYNERMED LDHH-L REAGENT KIT Synermed, Inc. CFJ Class II 1992-03-23
K920350 CHEM-CHEM MULTI-ANALYTE (MODIFIED) Streck Laboratories, Inc. JJY Class I 1992-03-23
K920888 MICROLITE MICROTITER PLATE LUMINOMETER ML2200 Dynatech Laboratories, Inc. KHO Class I 1992-03-19
K920559 ABBOTT VERTEX ANALYZER Abbott Laboratories JJJ Class I 1992-03-19
K915803 DMA LD KINETIC PROCEDURE Data Medical Associates, Inc. CFJ Class II 1992-03-18
K920345 PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) Medix Biotech, Inc. CFT Class I 1992-03-18
K920442 IMMUCHEM TSH-MW ELISA Icn Biomedicals, Inc. JLW Class II 1992-03-18
K914958 RIATRAC PLUS Becton Dickinson Advanced Diagnostics JJY Class I 1992-03-18
K915113 ENCORE Heraeus Kulzer, Inc. JJQ Class I 1992-03-18
K915366 MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER Ciba Corning Diagnostics Corp. JJE Class I 1992-03-17
K914167 CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE Eastman Kodak Company CKE Class II 1992-03-17
K915823 DSL ACTIVE SHBG (DSL 7400) Diagnostic Systems Laboratories, Inc. CDZ Class I 1992-03-17
K914204 TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3 Medical Analysis Systems, Inc. JJY Class I 1992-03-17
K920603 TRACE MAGNESIUM - ARSENAZO REAGENT Trace America, Inc. JGJ Class I 1992-03-11
K920411 IMMULITE HLH Cirrus Diagnostics, Inc. CEP Class I 1992-03-11
K920216 SYN ELISA MICRO ALBUMIN Elias U.S.A., Inc. JIR Class I 1992-03-11
K914877 IL TEST(TM) UREA NITROGEN Instrumentation Laboratory CO CDQ Class II 1992-03-11
K920419 IL TEST DAT CAL/CONTROL SET D/E Instrumentation Laboratory CO DLG Class I 1992-03-11
K920160 LH GEN III SELF-TEST/CONCEIVE Quidel Corp. CEP Class I 1992-03-11
K920337 MILES LIPASE SERA-PAK METHOD Heraeus Kulzer, Inc. CHI Class I 1992-03-11
K915680 AMERLITE PROCESSING CENTER Eastman Kodak Company JJQ Class I 1992-03-11
K920299 MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. CFL Class I 1992-03-04
K920336 MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD Heraeus Kulzer, Inc. CIT Class II 1992-03-04
K912580 FIRST CHOICE Polymer Technology Corp. CGA Class II 1992-03-04
K920583 ABBOTT QUICKSTART AMYLASE, #5AXX Em Diagnostic Systems, Inc. JFJ Class II 1992-03-02
K914886 SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) Serono-Baker Diagnostics, Inc. CGR Class II 1992-03-02
K915164 SRI TESTOSTERONE ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. CDZ Class I 1992-03-02
K915325 TSH CONTROL Polymedco, Inc. JJX Class I 1992-03-02
K920247 AMERLITE MAB FT4 ASSAY Eastman Kodak Company CEC Class II 1992-03-02
K915727 ACTH IRMA KIT II MITSUBISHI YUKA Mitsubishi Yuka America, Inc. CKG Class II 1992-03-02
K920504 MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. CEP Class I 1992-03-02
K915705 ACID PHOSPHATASE REAGENT SET Tech Intl. Co. CKE Class II 1992-02-27
K915707 AMMONIA REAGENT SET Tech Intl. Co. JIF Class I 1992-02-26
K915492 RSP MEGA SAMPLE PROCESSOR Tecan U.S., Ltd. JQW Class I 1992-02-21
K914158 URIC ACID REAGENT SET Tech Intl. Co. KNK Class I 1992-02-21
K920136 WATERS 717 AUTOSAMPLER Millipore Corp. LDM Class I 1992-02-19
K915332 MODEL 795 FLUOROMETER/DENSITOMETER Ciba Corning Diagnostics Corp. JQT Class I 1992-02-18
K915380 MICROPROTEIN-PR Sigma Diagnostics, Inc. CEK Class II 1992-02-18
K920230 AFFINITY PRG Bd Becton Dickinson Vacutainer Systems Preanalytic JLS Class I 1992-02-18
K915706 LIPASE REAGENT SET Tech Intl. Co. CET Class I 1992-02-18
K914135 AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 Amersham Corp. CFT Class I 1992-02-18
K913744 IL TEST(TM) AMLYLASE Instrumentation Laboratory CO JFJ Class II 1992-02-18
K920047 IMX ESTRADIOL Abbott Laboratories CHP Class I 1992-02-18
K920184 ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. Mbo Laboratories, Inc. GIM Class II 1992-02-18
K920078 AFFINITY B12 Bd Becton Dickinson Vacutainer Systems Preanalytic CDD Class II 1992-02-14
K915195 ENZYMUN-TEST TSH Boehringer Mannheim Corp. JLW Class II 1992-02-14
K920253 MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. JHI Class II 1992-02-14
K915792 DOCUMENT CK ISOENZYMES CONTROL Casco Standards CDP Class II 1992-02-06
K914890 N/T PROTEIN CONTROL UY Behring Diagnostics, Inc. JJY Class I 1992-02-06
K914467 MILENIA TOTAL T3 Diagnostic Products Corp. CDP Class II 1992-02-06
K915710 AMYLASE (COLORIMETRIC) REAGENT SET Tech Intl. Co. JFJ Class II 1992-01-30
K914885 BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST Beckman Instruments, Inc. CEK Class II 1992-01-30
K915806 MILENIA DATA REDUCTION Diagnostic Products Corp. JJX Class I 1992-01-30
K912027 CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL Enzyme Technology, Inc. CIC Class II 1992-01-30
K914160 CHOLESTEROL REGEANT SET Tech Intl. Co. CHH Class I 1992-01-30
K915797 CALIBRATOR Alko Diagnostic Corp. JIX Class II 1992-01-30
K915106 DIMENSION AR CLINICAL CHEMISTRY SYSTEM Dupont Medical Products JJE Class I 1992-01-28
K914166 ABL505 BLOOD GAS & ELECTROLYTE SYSTEM Radiometer America, Inc. CHL Class II 1992-01-28
K915084 BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT Beckman Instruments, Inc. CDT Class I 1992-01-28
K915235 CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT Incstar Corp. CDX Class II 1992-01-28
K915701 KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION Eastman Kodak Company JHI Class II 1992-01-27
K915177 NOVA 5 NA/K/C1 ALALYZER Nova Biomedical Corp. CEM Class II 1992-01-27
K915555 SYNERMED AST/GOT REAGENT KIT Synermed, Inc. CIT Class II 1992-01-27
K915570 GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT Incstar Corp. CDZ Class I 1992-01-27
K914159 GLUCOSE REAGENT SET Tech Intl. Co. CGA Class II 1992-01-27
K915709 CREATINE KINASE-MB (CK-MB) REAGENT SET Tech Intl. Co. CGS Class II 1992-01-27
K914809 MP MINI PHOTOMETER Artel, Inc. JJX Class I 1992-01-27
K915178 NOVA 11 NA/K/LI ANALYZER Nova Biomedical Corp. CEM Class II 1992-01-27
K915708 INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET Tech Intl. Co. CEO Class I 1992-01-22
K915284 STACKING MICROPLATE WASHER Denley Instruments, Inc. JQW Class I 1992-01-22
K914909 IL TEST(TM) CALIBRATION SET SP Instrumentation Laboratory CO JIX Class II 1992-01-22
K915176 NOVA 4 NA/K/C1/TCO2/LI ANALYZER Nova Biomedical Corp. JGS Class II 1992-01-15
K915732 ABBOTT QUICKSTART TIGLYCERIDES REAGENT Em Diagnostic Systems, Inc. CDT Class I 1992-01-15
K914429 DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) Diagnostic Systems Laboratories, Inc. JKR Class II 1992-01-15
K914756 ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT Medix Biotech, Inc. JLW Class II 1992-01-15

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