meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1985-07-09

Clearances · page 93 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850390 CHOLESTEROL TEST SYSTEM Hans J. Brouwers & Assoc. CHH Class I 1985-07-09
K852286 DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST Sero-Immuno Diagnostics, Inc. JHJ Class II 1985-07-09
K852376 SIMULTANEOUS LH/FSH SYSTEM BY RIA American Bioclinical, Inc. CEP Class I 1985-07-09
K852292 DURAZYME UREA NITROGEN American Monitor Corp. CDQ Class II 1985-07-08
K852350 HDL CHOLESTEROL PRETREATMENT American Monitor Corp. LBR Class I 1985-07-08
K852274 ANSWER Armkel, LLC LCX Class II 1985-06-28
K844947 EMIT ANCILLARY REAGENTS Syva Co. KIE Class I 1985-06-28
K852201 ECHOCLONAL HCG IRMA Bio-Rad JHI Class II 1985-06-28
K851506 SERUM TRANSPORT VIALS, T25/SC, TZ10/SC Ncs Diagnostics, Inc. JKA Class II 1985-06-27
K850931 ALBUMIN Dilab, Inc. CIX Class II 1985-06-26
K851520 CK/LD ISOENZYMES CONTROLS(HUMAN) Seragen Diagnostics, Inc. JJT Class I 1985-06-25
K850938 CHOLESTEROL Dilab, Inc. CGO Class I 1985-06-25
K850936 TOTAL PROTEINS Dilab, Inc. CEK Class II 1985-06-25
K850934 PHOSPHORUS Dilab, Inc. CEO Class I 1985-06-25
K850907 CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ Cala Diagnostics JJT Class I 1985-06-25
K852066 PREGNANCY CARD TEST Em Diagnostic Systems, Inc. JHJ Class II 1985-06-25
K851808 ELECTROLYTE ANALYZER Ionetics, Inc. CEM Class II 1985-06-25
K850932 CREATININE Dilab, Inc. CGX Class II 1985-06-25
K852262 ASSIST CLINICAL CHEMISTRY ANALYZER Cooper Biomedical, Inc. JJE Class I 1985-06-25
K850933 URIC ACID Dilab, Inc. CDH Class I 1985-06-25
K851990 INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU Alpkem Corp. JIX Class II 1985-06-25
K852005 MG REAGENT Alpkem Corp. JGJ Class I 1985-06-25
K850727 BHCG-ROCHE EIA Hoffmann-La Roche, Inc. JHI Class II 1985-06-25
K852002 CA BUFFER CA DYE Alpkem Corp. CIC Class II 1985-06-25
K844894 PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES Slt Labinstruments, Inc. JJQ Class I 1985-06-25
K851950 TANDEM E PAP Hybritech, Inc. JFH Class II 1985-06-25
K851403 VENTREZYME ALLERGEN DATA REDUCTION SYSTEM Ventrex Laboratories, Inc. JQW Class I 1985-06-21
K851939 CORNING CERTAIN -ISE Corning Medical & Scientific JIX Class II 1985-06-14
K851329 MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA Corning Medical & Scientific JLW Class II 1985-06-13
K850930 GLUCOSE Dilab, Inc. CGE Class II 1985-06-10
K852131 BUN(ENDPOINT) REAGENT Sigma Diagnostics, Inc. CDQ Class II 1985-06-10
K852161 SERUM IRON/VIBC REAGENT SET Livonia Diagnostics, Inc. JIY Class I 1985-06-10
K851999 G-GT REAGENT Alpkem Corp. JQB Class I 1985-06-10
K850935 CHLORIDE Dilab, Inc. CHJ Class II 1985-06-10
K852001 AMY REAGENT Alpkem Corp. JFJ Class II 1985-06-10
K850937 UREA Dilab, Inc. CDW Class II 1985-06-10
K852006 TP BIURET REAGENT Alpkem Corp. CEK Class II 1985-06-10
K851933 CLINICAL CHEMISTRY ANALYTICAL SYSTEM Allied Instrumentation Laboratory JJF Class I 1985-06-10
K852130 GLUCOSE(TRINDER) REAGENT Sigma Diagnostics, Inc. CGA Class II 1985-06-10
K850929 CALCIUM Dilab, Inc. CIC Class II 1985-06-10
K851540 ESTRADIOL DIRECT RIA KIT Biotecx Laboratories, Inc. CHP Class I 1985-06-06
K850892 SOMATOMEDIN C BY RADIOIMMUNOASSAY Immuno Nuclear Corp. CFL Class I 1985-06-06
K851994 AST ASPARTATE AMINOTRANSFERASE REAGENT Alpkem Corp. CIT Class II 1985-06-03
K852047 SC-360 SPECTROPHOTOMETER Pharmacia, Inc. JJQ Class I 1985-05-31
K851980 ENDAB TSH Immunotech Corp. JLW Class II 1985-05-31
K852003 IP ACID REAGENT IP MOLY BDATE REAGENT Alpkem Corp. CEO Class I 1985-05-31
K851996 LD-L REAGENT Alpkem Corp. CFJ Class II 1985-05-31
K852068 TOTAL BILIRUBIN STANDARDS Data Medical Associates, Inc. JIS Class II 1985-05-31
K851120 DELFIA HTSH KIT Lkb Instruments, Inc. JLW Class II 1985-05-31
K851942 COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY Coulter Electronics, Inc. JJY Class I 1985-05-31
K852103 INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN Medical Analysis Systems, Inc. CEO Class I 1985-05-31
K852067 DIRECT BILIRUBEN CALIBRATIONS Data Medical Associates, Inc. JIT Class II 1985-05-31
K851998 ALP(ALKALINE)(PHOSPHATASE) REAGENT Alpkem Corp. CJE Class II 1985-05-30
K851995 ALT (ALANINE AMINO-THRANSFERASE)REAGENT Alpkem Corp. CKA Class I 1985-05-30
K852009 T-CHO REAGENT Alpkem Corp. CHH Class I 1985-05-30
K852010 TGL REAGENT Alpkem Corp. CDT Class I 1985-05-30
K851993 CRE BUFFER CRE DYE Alpkem Corp. CGX Class II 1985-05-30
K852007 ALB BCG REAGENT Alpkem Corp. CIX Class II 1985-05-30
K852000 CK-NAC REAGENT Alpkem Corp. CGS Class II 1985-05-30
K852008 T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL Alpkem Corp. CIG Class II 1985-05-30
K851997 LD-P REAGENT Alpkem Corp. CFJ Class II 1985-05-30
K851991 UN(UREASE)REAGENT UN(A-KETO)REAGENT Alpkem Corp. KNK Class I 1985-05-29
K851992 GLU(GOD) REAGENT Alpkem Corp. CGA Class II 1985-05-29
K852004 UA(URICASE) REAGENT Alpkem Corp. KNK Class I 1985-05-29
K851984 LKB-WALLAC 1230 ARCUS FLUOROMETER Lkb Instruments, Inc. KHO Class I 1985-05-24
K850858 OB-PH - PH TEST PAPER Uro Pharmaceuticals, Inc. LNW Class I 1985-05-24
K851930 TDX REA IRON/TIBC Abbott Laboratories JMO Class I 1985-05-24
K851923 AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE Amresco, Inc. CKA Class I 1985-05-24
K851945 VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM Varian Assoc., Inc. KZR Class I 1985-05-24
K851538 TRIGLYCERIDE(TRINDER) PROCEDURE Data Medical Associates, Inc. CDT Class I 1985-05-20
K843375 ELVI 655 FLAME PHOTOMETER Logos Scientific, Inc. JJO Class I 1985-05-20
K851514 ULTRA-VIOLET GLUCOSE REAGENT Bio-Analytics Laboratories, Inc. CFA Class I 1985-05-20
K851849 CREATINE LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CGX Class II 1985-05-20
K851865 AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE Amresco, Inc. CIT Class II 1985-05-20
K851151 FISHER DIAGNOSTICS KDA CALIBRATOR II Fisher Scientific Co., LLC JIX Class II 1985-05-20
K851150 FISHER DIAGNOSTICS KDA CALIBRATOR I Fisher Scientific Co., LLC JIX Class II 1985-05-20
K851513 ULTRA-VIOLET BUN REAGENT KIT Bio-Analytics Laboratories, Inc. CDQ Class II 1985-05-20
K851911 MULTI FUNCTION BLOOD GAS CONTROL Bionostics, Inc. JJS Class I 1985-05-20
K851676 TDX TOTAL T3 Abbott Laboratories CDP Class II 1985-05-20
K851877 TOTAL PROTEIN LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CEK Class II 1985-05-20
K851572 NOVASPEC VISIBLE SPECTROPHOTOMETER Lkb Instruments, Inc. JJQ Class I 1985-05-20
K850638 LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS Behring Diagnostics, Inc. MSJ Class I 1985-05-15
K851619 GEN PROFILER SYSTEM Electro-Cucleonics, Inc. JJG Class I 1985-05-14
K851638 CLINALYZER MODEL VX-1000 Alpkem Corp. JJE Class I 1985-05-13
K851154 ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 Astral Medical Systems JQT Class I 1985-05-13
K851259 HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT Nichols Institute Diagnostics CFL Class I 1985-05-13
K850859 COBAS CALIBRATOR SERUM Roche Diagnostic Systems, Inc. JIX Class II 1985-05-10
K851670 CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ Medical Analysis Systems, Inc. JIT Class II 1985-05-10
K851076 UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST United Biotech, Inc. JHI Class II 1985-05-10
K850995 SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P Awareness Technology, Inc. JJQ Class I 1985-05-10
K851542 RFA-300 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. JJF Class I 1985-05-10
K851521 LD-1(IMMUNO) SEPARATION SET Seragen Diagnostics, Inc. CEX Class II 1985-05-10
K851657 DEMAND MAGNESIUM Cooper Biomedical, Inc. JGJ Class I 1985-05-10
K850994 SPECTRA 1 FILTER PHOTOMETER Awareness Technology, Inc. JJQ Class I 1985-05-10
K851395 SANDARE IRON-BINDING CAPACITY PROCEDURE Sandare Chemical Co., Inc. JMO Class I 1985-05-07
K851361 AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM Amersham Corp. CGJ Class I 1985-05-07
K850993 SMART ALEX II MULTI-FILTER PHOTOMETER Awareness Technology, Inc. JJQ Class I 1985-05-07
K851172 COBAS MIRA Roche Diagnostic Systems, Inc. JJF Class I 1985-05-02
K850992 PREGNA-ZYME Armkel, LLC JHI Class II 1985-05-01
K851394 SANDARE IRON PROCEDURE Sandare Chemical Co., Inc. JIY Class I 1985-04-30

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