meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1984-07-18

Clearances · page 98 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842242 UREA ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CDQ Class II 1984-07-18
K842246 URIC ACID ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) KNK Class I 1984-07-18
K842265 ORTHO BRAND HOME PREGNANCY TEST Advanced Care Products LCX Class II 1984-07-17
K842168 ATAGO URINE SPECIFIC GRAVITY & SERUM Kyoto Diagnostics, Inc. JRE Class I 1984-07-16
K842110 SLIDE PREGNANCY TEST Immunostics Co., Inc. JHJ Class II 1984-07-12
K842221 WAKO GLUCOSE C Wako Pure Chemical Industries, Ltd. CGA Class II 1984-07-12
K841415 BETA STICK, PREGNANCY TEST Quidel Corp. LCX Class II 1984-07-11
K841891 VARIAN 3300 & 3400 GAS CHROMATOGRAPHS Varian Assoc., Inc. KZQ Class I 1984-07-09
K842167 TBG RIA Syncor Intl. Corp. CEE Class II 1984-07-09
K842029 TRIGLYCERIDES-GPO REAGENT Reagents Applications, Inc. CDT Class I 1984-07-09
K841575 SENTECH'S ULAB 1000 CLINICAL CHEM. Sen Tech Medical Corp. CEM Class II 1984-07-06
K842211 ULTRA CHEM ENZYMATIC TRIGLYCERIDE Em Diagnostic Systems, Inc. CDT Class I 1984-07-06
K841884 KODAK EKTACHEM CONTROL Eastman Kodak Company JJY Class I 1984-07-06
K841043 BEHRING ELISA PROCESSOR M Behring Diagnostics, Inc. JQW Class I 1984-07-06
K842134 SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY Somas Medical Industries, Inc. JGQ Class II 1984-07-06
K842079 GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY Immuno Nuclear Corp. CGC Class I 1984-06-26
K842207 WAKO B.G. PRETEST STRIPS Healthdyne, Inc. CGA Class II 1984-06-26
K840462 VITAMIN B12 57CO/FOLATE 125I - Corning Medical & Scientific CDD Class II 1984-06-25
K831830 LYRIS MODULAR INFO SYSTEM Biovation, Inc. JQP Class I 1984-06-25
K841927 T3 UPTAKE Syncor Intl. Corp. KHQ Class II 1984-06-25
K842013 SIGMA PROCEDURE 47-UV Sigma Chemical Co. CGS Class II 1984-06-25
K841955 DUPONT ACA MAGNESIUM CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1984-06-25
K842010 THYROXINE-BINDING GLOBULIN RADIOUMMU Nichols Institute Diagnostics CEE Class II 1984-06-25
K841947 ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT Sorin Biomedica, Fiat, USA, Inc. CHP Class I 1984-06-25
K841948 TESTOSTERONE DIRECT RADIOIMMUNOASSAY Sorin Biomedica, Fiat, USA, Inc. CDZ Class I 1984-06-25
K841963 GASTRIN RIA Syncor Intl. Corp. CGC Class I 1984-06-25
K834226 FLAME PHOTOMETERS Dr. Bruno Lange GmbH JJO Class I 1984-06-22
K841916 ABBOTT PROJECT I Abbott Laboratories JJE Class I 1984-06-22
K841854 BHCG RIA Syncor Intl. Corp. JHI Class II 1984-06-22
K840962 REFLOCHECK-S Boehringer Mannheim Corp. CGA Class II 1984-06-22
K841853 PREG-BETA ONE HOUR TUBE TEST Intl. Diagnostic, Inc. JHJ Class II 1984-06-22
K841464 CHANGES IN THE CHEMICAL COMP. OF 5 Nova Biomedical Corp. JIX Class II 1984-06-22
K841424 ELECTROLYTE ANALYZER SERA-210 Horiba Instruments, Inc. JGS Class II 1984-06-22
K841302 DIAGNON FOLATE 125I RIA KIT Diagnon Corp. CGN Class II 1984-06-22
K841887 PARAMAX IRON BLANK REAGENT American Dade JIY Class I 1984-06-22
K841886 PARAMAX IRON REAGENT American Dade JIY Class I 1984-06-22
K842011 CHLORIDE TEST KIT Mallinckrodt Critical Care CHJ Class II 1984-06-22
K842019 TIBC PRETREATMENT KIT E.I. Dupont DE Nemours & Co., Inc. JQE Class I 1984-06-22
K842056 ELVI 165 PROTEO SEROSKOP Logos Scientific, Inc. JQT Class I 1984-06-22
K842025 ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL Hi Chem, Inc. JGS Class II 1984-06-22
K841452 NOVA STAT CONTROL LEVELS 1/2/3 Nova Biomedical Corp. JJY Class I 1984-06-22
K840484 DIATRON EASYTEST BLOOD GLUCOSE MONI Medivix, Inc. CGA Class II 1984-06-22
K841821 CA-1511, IN VITRO RADIOIMMUNOASSAY Travenol Laboratories, S.A. JHI Class II 1984-06-22
K841917 SIGMS PROCED. 228 UV LACTATE DEHYDRO Sigma Diagnostics, Inc. CFJ Class II 1984-06-14
K841918 SIGMA PROCED. 245 ALKALINE PHOSPHATASE Sigma Diagnostics, Inc. CJE Class II 1984-06-14
K841783 BLOOD GAS CONTROL, LEVEL I(ACIDOSIS Bionostics, Inc. JJS Class I 1984-06-14
K841478 RIANEN CYCLIC-AMP RADIOIMMUNOASSAY New England Nuclear CHO Class II 1984-06-14
K841890 VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY Varian Assoc., Inc. KZR Class I 1984-06-14
K840064 UREA NITROGEN REAGENT SET Sterling Biochemical, Inc. CDQ Class II 1984-06-14
K842085 AUTOMATED EIA MICROPLATE READER EL310 Bio-Tek Instruments, Inc. JJQ Class I 1984-06-11
K841664 ENZYMATIC CO2 DIAGNOSTIC CHEMICAL Diagnostic Chemicals, Ltd. (Usa) KHS Class II 1984-06-08
K841703 TDX REA LDH Abbott Laboratories CFJ Class II 1984-06-08
K841892 RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT Reagents Applications, Inc. CIG Class II 1984-06-07
K842028 CM-TRISACRYL M DEAE-TRISACRYL M Lkb Instruments, Inc. KEA Class I 1984-06-07
K841726 DEMAND C02 Cooper Biomedical, Inc. KHS Class II 1984-06-07
K841525 OREIA II B-HCG PREGNANCY TEST KIT Organon, Inc. JHI Class II 1984-06-05
K841714 KYOTEST 2V, URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. JIL Class II 1984-05-31
K841715 KYOTEST UK URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. JIN Class I 1984-05-31
K841595 HEALTHCHECK HOME PREGNANCY TEST KIT Timex Medical Products Corp. LCX Class II 1984-05-31
K841702 TDX REA URIC ACID Abbott Laboratories KNK Class I 1984-05-31
K841804 ELVI 70 SAFETY CHAMBER Logos Scientific, Inc. JJN Class I 1984-05-31
K841713 KYOTEST UG URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. JIL Class II 1984-05-31
K840757 ELVI 444 BILITRON Logos Scientific, Inc. CIG Class II 1984-05-30
K840833 PREG BETA BLUS SLIDE Intl. Diagnostic, Inc. JHJ Class II 1984-05-30
K834616 AMNIO STAT-FLM AGGLUTINATION TEST Hana Biologics, Inc. JHG Class II 1984-05-25
K841609 COMPONENTS FOR PARTIAL PRESSURE ELEE Shaban Mfg. Co. CHL Class II 1984-05-25
K841610 COMPONENTS FOR POTASSIUM, SODIUM CHLO Shaban Mfg. Co. JGT Class II 1984-05-25
K841089 LINEAR CLOUD TONOMETER Linear Tonometers, Inc. LCH Class I 1984-05-22
K841606 BLOOD SPOT NEONATAL TSH RADIOIMMUNO Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1984-05-22
K841555 SIGMA PROCEDURE 16-UV Sigma Chemical Co. CFR Class II 1984-05-22
K841576 TECHNICON RA-1000 SYS T4-THYROXINE Technicon Instruments Corp. KLI Class II 1984-05-22
K841602 ACCURATE BETA 30 PREGNANCY TEST KIT Organon, Inc. LCX Class II 1984-05-22
K841557 ORTHO MICROWELL READER Ortho Diagnostic Systems, Inc. JJQ Class I 1984-05-22
K841601 TERUMO SENSIBEAD THYROXINE EIA KIT Terumo Medical Corp. KLI Class II 1984-05-22
K841503 KODAK EKTACHEM DT 60 ANALYZER Eastman Kodak Company JJE Class I 1984-05-22
K840868 AMRESCO E4A REAGENT SET American Research Products Co. JJE Class I 1984-05-22
K841456 VENTREXYME EIA CONTROLS IMMUNOASSAY Vxr, Inc. JIX Class II 1984-05-21
K841712 CAPILLARY GAS CHROMATOGRAPHIC COLUMNS Supelco, Inc. DII Class I 1984-05-21
K841471 ULTRA CHEM ENZYMATIC TRIGLYCERIDE Em Diagnostic Systems, Inc. CDT Class I 1984-05-16
K841466 TOTAL PROTEIN REAGENT BIURET Reagents Applications, Inc. CEK Class II 1984-05-16
K841573 INSULIN RADIOIMMUNOASSAY KIT Sorin Biomedica, Fiat, USA, Inc. CFP Class I 1984-05-16
K841417 POTASSIUM CHLORIDE SOLUTION -2 MOLAR Reagent Laboratory, Inc. JGS Class II 1984-05-16
K841433 CORNING LACTATE DEHYDROPHORETIC ASSAY Corning Medical & Scientific CFE Class II 1984-05-16
K841572 DIRECT BILIRUBIN REAGENT Hi Chem, Inc. CIG Class II 1984-05-16
K840883 UNIPAK 100 ANALYZER, 65156 & CHEMISTR Emd Chemicals, Inc. JJE Class I 1984-05-16
K841418 SODIUM ELECTRODE RINSE SOLUTION 2 Reagent Laboratory, Inc. JGS Class II 1984-05-16
K840828 KYOTEST 8V Kyoto Diagnostics, Inc. JMT Class I 1984-05-14
K834270 ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST Advanced Care Products LCX Class II 1984-05-14
K834387 YD STRIP GPH U21 Yd Pharmaceutical Corp. JIL Class II 1984-05-14
K840827 KYOTEST 5V Kyoto Diagnostics, Inc. CEN Class I 1984-05-14
K834386 YD STRIP GP U20 Yd Pharmaceutical Corp. JIL Class II 1984-05-14
K834218 DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - Tago, Inc. MSJ Class I 1984-05-11
K841118 PROLACTIN RIABEAD PROLACTIN RADIOIMM Abbott Laboratories CFT Class I 1984-05-11
K841422 VOLUME TEST DYE 6 Reagent Laboratory, Inc. JJO Class I 1984-05-11
K841421 DAILY WASH SOLUTION 5 Reagent Laboratory, Inc. JJO Class I 1984-05-11
K834385 YD STRIP GLUCOSE U19 Yd Pharmaceutical Corp. JIL Class II 1984-05-11
K841419 SODIUM & POTASSIUM STANDARD SOLUT Reagent Laboratory, Inc. JIX Class II 1984-05-11
K841420 SODIUM & POTASSIUM STANDARD SOL 80 Reagent Laboratory, Inc. JIX Class II 1984-05-11
K841377 CREATININE - A.A.S. Advanced Analytical Systems, Inc. CGX Class II 1984-05-11
K841024 VENTREZYME T4U IMMUNOASSAY T4U Ventrex Laboratories, Inc. CEE Class II 1984-05-09

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