meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1986-01-08

Clearances · page 91 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854523 ANALYST PHYSICIAN'S OFFICE PROFILER E.I. Dupont DE Nemours & Co., Inc. JJG Class I 1986-01-08
K854967 CRITIC - SF, ASSAYED Dimension Diagnostics JJY Class I 1986-01-07
K854838 LEE-BEAD BETA LH (EIA) Leeco Diagnostics, Inc. CEP Class I 1986-01-07
K853951 ISOTRAK AMYLASE TEST AMYLASE ISOENZYME Behring Diagnostics, Inc. CIJ Class II 1986-01-07
K854379 MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT Bioclinical Systems, Inc. JLW Class II 1986-01-07
K854716 NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 Nobel Scientific Industries, Inc. CIC Class II 1986-01-07
K854016 ASSERACHROM PROTEIN C KIT American Bioproducts Co. JLA Class I 1986-01-03
K854611 RAMP URINE HCG ASSAY Monoclonal Antibodies, Inc. JHI Class II 1985-12-30
K854708 DART CK-MB REAGENT SYSTEM Coulter Electronics, Inc. JHS Class II 1985-12-30
K854186 IN VITRO TEST DETERMINATION OF SGPT(ALT) Clinical Data, Inc. CKA Class I 1985-12-25
K853943 CRITIC C LEVEL I & II Dimension Diagnostics JJY Class I 1985-12-23
K854674 DSL ANDROSTENDIONE RIA (DSL #4200) Diagnostic Systems Laboratories, Inc. CDZ Class I 1985-12-19
K854784 ABSORBANCE (ABS) TEST PAK Diagnostic Systems JIT Class II 1985-12-19
K854671 DSL ACTIVE TESTOSTERONE RIA (DSL #4000) Diagnostic Systems Laboratories, Inc. CDZ Class I 1985-12-19
K853932 QUANTTEST TOTAL PROTEIN ASSAY Quantimetrix Corp. CEK Class II 1985-12-19
K854718 NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 Nobel Scientific Industries, Inc. CIX Class II 1985-12-19
K853142 OVUTIME OVULATION PREDICTOR TEST Advanced Care Products CEP Class I 1985-12-17
K854544 RAICHEM CO2 REAGENT Reagents Applications, Inc. KHS Class II 1985-12-13
K854650 DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) Diagnostic Systems Laboratories, Inc. CIZ Class I 1985-12-13
K854651 PARAAMAX CHLORIDE DETERMINATION BY ISE American Dade CGJ Class I 1985-12-13
K854649 DSL PROGESTERONE RIA (DSL #3400) Diagnostic Systems Laboratories, Inc. JLS Class I 1985-12-13
K854076 MGA 2000 GAS ANALYSER Airspec , Ltd. DOP Class I 1985-12-11
K853930 QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT Quantimetrix Corp. CEK Class II 1985-12-10
K853840 LIFE WATCH RESPIRATORY MONITOR The Perkin-Elmer Corp. CHL Class II 1985-12-09
K852760 LBK 1244 DELFIA HCG KIT Lkb Instruments, Inc. JHI Class II 1985-12-05
K854324 PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. CDX Class II 1985-12-05
K854608 ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT. Nova Biomedical Corp. CHL Class II 1985-12-05
K854210 TERUMO SENSIBEAD EIA COLORIMETER Terumo Medical Corp. JJQ Class I 1985-12-05
K854057 PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE Beckman Instruments, Inc. JHO Class I 1985-12-05
K854585 ULTRAZYME PLUS & SYSTEMATE LDH Em Diagnostic Systems, Inc. CFJ Class II 1985-12-05
K853621 REPLACEMENT PUMP TUBING Shaban Mfg. Co. JJE Class I 1985-12-05
K854104 IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY) Immunchem Corp. JHI Class II 1985-12-05
K854501 CK(OPTIMIZED) REAGENT Sigma Diagnostics, Inc. CGS Class II 1985-12-04
K853405 ELECTROLYTE ANALYZER SERA-252 Horiba Instruments, Inc. CHL Class II 1985-12-04
K853925 QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA Nms Pharmaceuticals, Inc. JHI Class II 1985-12-02
K854028 AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER Verified Medical Research, Inc. JIW Class II 1985-12-02
K854345 TECHNICON RA-500 SYSTEM Technicon Instruments Corp. JJC Class I 1985-11-26
K854024 CORNING MAGIC MAB HCG RADIOIMMUNOASSAY Corning Medical & Scientific JHI Class II 1985-11-26
K854540 RAICHEM/K.E Reagents Applications, Inc. JJQ Class I 1985-11-26
K854177 IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE Clinical Data, Inc. CGA Class II 1985-11-25
K854188 IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO Clinical Data, Inc. CEO Class I 1985-11-25
K854178 IN-VITRO TEST FOR THE DETERMINATION OF CREATININE Clinical Data, Inc. CGX Class II 1985-11-25
K854366 ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD American Monitor Corp. CDT Class I 1985-11-25
K854182 IN-VITRO TEST DETERMINATION OF TRIALYCERIDE Clinical Data, Inc. CDT Class I 1985-11-25
K854187 IN-VITRO TEST DETERMINATION OF SGOT (AST) Clinical Data, Inc. CIS Class II 1985-11-25
K854179 IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL Clinical Data, Inc. CHH Class I 1985-11-25
K854503 AST(OPTIMIZED) REAGENT Sigma Diagnostics, Inc. CIT Class II 1985-11-25
K854181 IN-VITRO TEST DETERMINATION OF ALBUMIN Clinical Data, Inc. CIX Class II 1985-11-25
K854553 TOTAL PROTEIN American Monitor Corp. CEK Class II 1985-11-25
K854185 IN-VITRO TEST DETERMINATION OF URIC ACID Clinical Data, Inc. KNK Class I 1985-11-25
K854502 ALT(OPTIMIZED) REAGENT Sigma Diagnostics, Inc. CKA Class I 1985-11-25
K854180 IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN Clinical Data, Inc. CIG Class II 1985-11-25
K854419 TDX CORTISOL Abbott Laboratories JFT Class II 1985-11-25
K854240 CALCITONIN RIA KIT Diagnostic Systems Laboratories, Inc. JKR Class II 1985-11-22
K854335 GLUCOSE REAGENT SET (GOD/TRINDER) Sterling Diagnostics, Inc. CGA Class II 1985-11-22
K854260 CHEMPRO 1000 Sen Tech Medical Corp. CGA Class II 1985-11-19
K854303 MR 700 MICROPLATE READER 012-700-1000 Dynatech Laboratories, Inc. JJQ Class I 1985-11-19
K854243 ES 22 Boehringer Mannheim Corp. JJE Class I 1985-11-19
K854055 I.C.L.S. COMPULYZER Integrated Computerized Laboratory Systems, Inc. JJG Class I 1985-11-19
K854066 DOUBLE ANTIBODY C-PEPTIDE RIA KIT Diagnostic Products Corp. JKD Class I 1985-11-12
K854298 IRON Boehringer Mannheim Corp. CEM Class II 1985-11-12
K854138 KODAKEKTACHEM DTR MODULE Eastman Kodak Company JJE Class I 1985-11-12
K854305 DART IRON & IRON BINDING CAPACITY REAGENT Coulter Electronics, Inc. CFM Class I 1985-11-12
K852790 ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT Nova Biomedical Corp. CHL Class II 1985-11-12
K854152 TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN Technicon Instruments Corp. CDT Class I 1985-11-05
K850690 ANTISERUM TO HUMAN APOLIPOPROTEIN B Kent Laboratories, Inc. MSJ Class I 1985-11-01
K850691 ANTISERUM TO HUMAN APOLIPOPROTEIN A-I Kent Laboratories, Inc. MSJ Class I 1985-11-01
K853068 ILEX PROMPT CLINICAL CHEMISTRY ANALYER Ilex Corp. CEM Class II 1985-10-31
K851164 DENTOCULT CULTURE-PADDLE Orion Corp. JJJ Class I 1985-10-29
K854025 HITACHI 704 Boehringer Mannheim Corp. JJE Class I 1985-10-28
K853854 ASTRA SYSTEMS CHOLESTEROL REAGENT Beckman Instruments, Inc. CHH Class I 1985-10-28
K853681 SIGMA 610 FOR PROTEIN IN URINE & CSF Sigma Diagnostics, Inc. CEK Class II 1985-10-28
K854092 DMA CALIBRATORS Data Medical Associates, Inc. JIX Class II 1985-10-25
K854087 NML TSH IRMA Organon Teknika Corp. JLW Class II 1985-10-25
K854119 ACCURACY Columbia Diagnostics, Inc. JJY Class I 1985-10-25
K852392 EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE Helena Laboratories CGS Class II 1985-10-22
K853977 BETA-TSH-IRMA Leeco Diagnostics, Inc. JLW Class II 1985-10-22
K853949 DEMAND ACID PHOSPHATASE REAGENT Cooper Biomedical, Inc. CKB Class II 1985-10-16
K853837 LH/FSH RADIOIMMUNOASSAY KIT Bioclinical Group CEP Class I 1985-10-16
K853978 TDX AMYLASE Abbott Laboratories CIX Class II 1985-10-15
K853888 AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & American Research Products Co. CGX Class II 1985-10-15
K853865 PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO Pantex, Div. Bio-Analysis, Inc. CDZ Class I 1985-10-15
K853866 PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS Pantex, Div. Bio-Analysis, Inc. CHP Class I 1985-10-15
K853603 CANTROL URINE DIPSTICK CONTROL TWO LEVELS Canyon Diagnostics, Inc. JJW Class I 1985-10-08
K853906 LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) Biodiagnostic Intl JJY Class I 1985-10-04
K853784 C-TERMINAL PTH RIA KIT Diagnostic Systems Laboratories, Inc. CEW Class II 1985-10-04
K853871 QCA ENZYMATIC CHOLESTEROL Bd Becton Dickinson Vacutainer Systems Preanalytic CHH Class I 1985-10-04
K853867 PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY Pantex, Div. Bio-Analysis, Inc. JKC Class I 1985-10-04
K853284 MYREADER 7 Scientific Sales Intl., Inc. JJQ Class I 1985-10-04
K853832 LYTENING 1 Amdev, Inc. JGS Class II 1985-10-04
K853931 QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL Quantimetrix Corp. JJY Class I 1985-10-04
K853703 VENTREZYME T3 IMMUNOASSAY T3 Vxr, Inc. CDP Class II 1985-10-04
K853269 PREGNA/TEST Modern Diagnostics, Inc. LCX Class II 1985-10-03
K853853 TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC Technicon Instruments Corp. JGJ Class I 1985-10-03
K851822 BETA SCAN TRENDS METER Orange Medical Instruments, Inc. CGA Class II 1985-10-03
K853224 PHASE II B-12/FOLATE KIT Medical & Scientific Designs, Inc. CDD Class II 1985-10-03
K853717 ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM Nichols Institute Diagnostics JLW Class II 1985-10-02
K853391 MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 Eiken Chemical Co., Inc. JJE Class I 1985-10-01
K853258 BETA-HCG MICROTITER PREGNANCY TEST Modern Diagnostics, Inc. JHI Class II 1985-10-01
K853748 VENTRESCREEN HCG URINE Vxr, Inc. JHI Class II 1985-10-01

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