meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
73
Latest Decision
1984-05-09

Clearances · page 99 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K841182 MULTIPLE CHEM. MODULE FOR ANALYSIS Beckman Instruments, Inc. CHH Class I 1984-05-09
K841181 ASTRA SYS INORGANIC PHOSPHORUS CHEM Beckman Instruments, Inc. CEO Class I 1984-05-09
K841076 ION SELECTIVE ELECTRODE Cooper Biomedical, Inc. JJE Class I 1984-05-07
K840088 BIODEX ACT-O-KIT TSH-RIA- Biodan Medical Systems, Ltd. JLW Class II 1984-05-07
K840222 CORNING IMMO PHASE FREE T3 Corning Medical & Scientific CDP Class II 1984-05-07
K841081 VENTREZYME BETA-HCG IMMUNOASSAY HCG Ventrex Laboratories, Inc. JHI Class II 1984-05-07
K840768 CENTRIFUGES Heraeus-Christ GmbH JQC Class I 1984-05-07
K840549 CK-B RIA KIT Diagnostic Systems Laboratories, Inc. JHX Class II 1984-05-07
K841094 HUMAN GROWTH HORMONE RIA KIT Diagnostic Products Corp. CFL Class I 1984-05-07
K841259 DETERMINATION OF MAGNESIUM IN SERUM OR Sigma Chemical Co. JGJ Class I 1984-05-07
K841080 TECHNICON RA-1000 SYS CO2 Technicon Instruments Corp. CHS Class II 1984-05-02
K841352 ND1200 RIA COUNTER Nuclear Data, Inc. JJJ Class I 1984-05-02
K841288 ELVI 18 Logos Scientific, Inc. JJN Class I 1984-05-02
K841333 PROGESTERONE DIRECT RIA KIT-RADIOIMM Biotecx Laboratories, Inc. JLS Class I 1984-05-02
K841066 SGOT-UV REAGENT SET Medical Specialties, Inc. CIT Class II 1984-05-01
K834490 GELSCAN SOFTWARE 2190 Lkb Instruments, Inc. JQP Class I 1984-05-01
K841067 URIC ACID REAGENT SET Medical Specialties, Inc. CDH Class I 1984-05-01
K841055 GLUCOSE ENZYMATIC REAGENT SET Medical Specialties, Inc. CGA Class II 1984-05-01
K841053 CHOLESTEROL REAGENT SET ENZYMATIC Medical Specialties, Inc. CHH Class I 1984-05-01
K841056 HDL PRECIPITANT REAGENT SET Medical Specialties, Inc. JHM Class I 1984-05-01
K841023 COATED TUBE HCG IMMUNOASSAY HCG Ventrex Laboratories, Inc. JHI Class II 1984-05-01
K841054 DIRECT GLUCOSE REAGENT SET Medical Specialties, Inc. CGE Class II 1984-05-01
K840996 URINE ANALYZER SYSTEM Kyoto Diagnostics, Inc. KQO Class I 1984-05-01
K841069 SERUM TOTAL PROTEIN REAGENT SET Medical Specialties, Inc. CEK Class II 1984-05-01
K841060 SGPT REAGENT SET Medical Specialties, Inc. CKA Class I 1984-05-01
K841059 SGPT REAGENT SET Medical Specialties, Inc. CKD Class I 1984-05-01
K841058 LDH-UV REAGENT SET Medical Specialties, Inc. CFJ Class II 1984-05-01
K841063 ALBUMIN REAGENT SET Medical Specialties, Inc. CIX Class II 1984-05-01
K841068 UREA NITROGEN REAGENT SET Medical Specialties, Inc. CDW Class II 1984-05-01
K841065 SGOT REAGENT SET Medical Specialties, Inc. CIQ Class II 1984-05-01
K841052 CHOLESTEROL REAGENT SET Medical Specialties, Inc. CHD Class I 1984-05-01
K841061 PHOPHORUS REAGNET SET Medical Specialties, Inc. CEO Class I 1984-05-01
K841049 URIC ACID REAGENT SET ENZYMATIC Medical Specialties, Inc. KNK Class I 1984-05-01
K841062 TRIGLYCERIDE REAGENT SET Medical Specialties, Inc. CDT Class I 1984-05-01
K841051 SERUM CALCIUM REAGENT SET Medical Specialties, Inc. CIC Class II 1984-05-01
K840848 BIOSURE Helena Laboratories JJW Class I 1984-05-01
K841050 TOTAL BILIRUBIN REAGENT SET Medical Specialties, Inc. CIG Class II 1984-05-01
K841064 ALKALINE PHOSPHOTASE REAGENT SET Medical Specialties, Inc. CIO Class II 1984-05-01
K841070 CREATININE REAGENT SET Medical Specialties, Inc. JFY Class II 1984-05-01
K840901 PHASE II FREE T4 KIT Medical & Scientific Designs, Inc. CEC Class II 1984-04-25
K840486 TOTAL BILIRUBIN REAGENT Somas Medical Industries, Inc. CIG Class II 1984-04-25
K840328 PHASE II HCG KIT Medical & Scientific Designs, Inc. JHI Class II 1984-04-19
K840738 PLUS URINE HCG ASSAY Monoclonal Antibodies, Inc. JHJ Class II 1984-04-19
K840977 LIQUID CHROMATOGRAPHIC DETECTOR LC-95 The Perkin-Elmer Corp. KZR Class I 1984-04-19
K840938 HIGH SPEED DISPENSER Micromedic Systems JQW Class I 1984-04-19
K841047 PARAMAX CHLORIDE REAGENT American Dade CHJ Class II 1984-04-19
K840829 KYOTEST UGK Kyoto Diagnostics, Inc. JIL Class II 1984-04-19
K840985 TRISACRYL GF 05 & TRISACRYL GF 2000 Lkb Instruments, Inc. DJY Class I 1984-04-19
K841042 MATCHED COMPONENT SET RADIOIMMUNOASSAY Cambridge Medical Technology CDZ Class I 1984-04-19
K840959 FREE T3 SOLID PHASE RADIOIMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CDP Class II 1984-04-18
K840902 ENDAB ESTRIOL UNCONJUGATED Immunotech Corp. CGI Class I 1984-04-18
K840887 AMRESCO E2A REAGENT SET 0562 & 0626 American Research Products Co. CEM Class II 1984-04-18
K840880 EKTACHEM CLINICAL CHEM. SLIDES Eastman Kodak Company CIG Class II 1984-04-18
K840852 IMMPULSE T4 ASSAY REAGENTS Paragon Diagnostics, Inc. CDX Class II 1984-04-18
K840872 RAICHEM CREATININE REAGENT Reagents Applications, Inc. CGX Class II 1984-04-18
K840886 HYDROXYPROGESTERONE BY RIA 17A Radioassay Systems Laboratories, Inc. JLS Class I 1984-04-18
K840458 BIOTIS ABNORMAL CLINICAL CHEM SERUM- Otisville Biotech, Inc. JJY Class I 1984-04-17
K840843 POTASSIUM CHLORIDE TABLETS Bionostics, Inc. CHL Class II 1984-04-17
K840771 ALCOHOL & AMMONIA CALIBRATOR I American Dade JIT Class II 1984-04-13
K841214 LABSYSTEMS UNISKAN Labsystems, Inc. JJQ Class I 1984-04-13
K840778 LACTATE REAGENT American Dade KHP Class I 1984-04-13
K840412 OVU STICK URINE HLH KIT Monoclonal Antibodies, Inc. CEP Class I 1984-04-13
K840781 URIC ACID REAGENT American Dade KNK Class I 1984-04-13
K834505 HUMAN SERUM ELECTROLYTE CONTROL-LIQUID Quantimetrix Corp. JJR Class I 1984-04-13
K840677 HDL EZ-TZ3 CHOLESTEROL REAGENT KIT Preventive Diagnostics Corp. LBS Class I 1984-04-13
K840784 PARAMAX MAGNESIUM REAGENT American Dade JGJ Class I 1984-04-13
K840793 CK/MB IMMUNO-ISOENZYME CONTROL SERUM Seragen Diagnostics, Inc. JJT Class I 1984-04-13
K840496 ISOSTAT MICROBIAL TUBE PROCESSING E.I. Dupont DE Nemours & Co., Inc. JKA Class II 1984-04-13
K840779 NEONATAL BILIRUBIN REAGENT American Dade CIG Class II 1984-04-13
K833396 C-PEPTIDE RADIOIMMUNOASSAY TEST KIT Serono Diagnostics, Inc. JKD Class I 1984-04-13
K840457 NORMAL CLINICAL CHEM. CONTROL SERUM- Otisville Biotech, Inc. JJY Class I 1984-04-13
K845052 PARAMAX TOTAL PROTEIN REAGENT TP American Dade CEK Class II 1984-04-13
K840782 ALBUMIN REAGENT American Dade CIX Class II 1984-04-13
K840772 ALCOHOL & AMMONIA CALIBRATOR II American Dade JIT Class II 1984-04-13
K832977 FLOW-PAC CPK REAGENT SET American Research Products Co. JHY Class II 1984-04-05
K840780 TRIGLYCERIDES REAGENT American Dade CDT Class I 1984-04-05
K840186 SMI DIGITRON Scientific Manufacturing Industries JRC Class I 1984-04-05
K840785 PARAMAX UREA NITROGEN REAGENT American Dade CDQ Class II 1984-04-05
K840777 DIRECT BILIRUBIN REAGENT American Dade CIG Class II 1984-04-05
K840650 B-NEOCEPT 30 Organon, Inc. JHJ Class II 1984-04-04
K833934 ADRENOCORTICOTROPIC HORMONE TEST Clinetics Corp. CKG Class II 1984-04-04
K840588 AMERLEX HUMAN PLACENTAL LACTOGEN Amersham Corp. JMF Class II 1984-04-04
K840770 PARAMAX AMMONIA REAGENTT American Dade JIF Class I 1984-04-04
K840502 CATS-CLINICAL LAB COMPUTER SOFTWARE- Precision Technology, Inc. JQP Class I 1984-04-04
K840706 ASPARTATE AMINOTRANSFERASE REAGENT American Dade CIT Class II 1984-04-04
K840379 PARATHYROID HORMONE ANALYSIS PRODUCT Nichols Institute Diagnostics CEW Class II 1984-04-04
K840473 VENTREZYME T4 IMMUNOASSAY T4 Vxr, Inc. KLI Class II 1984-04-04
K840775 CARBON DIOXIDE CALIBRATOR II American Dade JIT Class II 1984-04-04
K840783 CREATINE KINASE MB REAGENT American Dade CGS Class II 1984-04-04
K840200 PROGRESS SELECTIVE DHEMISTRY ANALYZ Kone Instruments, Inc. JJF Class I 1984-04-04
K840776 PARAMAX CHOLESTEROL REAGENT American Dade CHH Class I 1984-04-04
K840773 CARBON DIOXIDE REAGENT American Dade KHS Class II 1984-04-04
K840606 EKTACHEM CLINICAL CHEM. SLIDES Eastman Kodak Company CIG Class II 1984-04-04
K840774 CARBON DIOXIDE CALIBRATOR I American Dade JIT Class II 1984-04-04
K840618 LIQUI-URA CHEMISTRY URINE CONTROLS Biodiagnostic Intl JJW Class I 1984-04-04
K840676 PDC HDL EZ-SEP CHOLESTEROL REAGENT Preventive Diagnostics Corp. LBS Class I 1984-04-04
K840501 ACCULAB SUPPLIES CHEMICAL ANALYZERS Precision Technology, Inc. JJE Class I 1984-04-04
K840661 PARAMAX ACID PHOSPHATASE REAGENT American Dade CKB Class II 1984-04-04
K840557 REAGENTS & STANDARDS IL 501 NA/K Shaban Mfg. Co. JGS Class II 1984-04-04
K840853 IMMPULSE TBC ASSAY REAGENTS Paragon Diagnostics, Inc. KHQ Class II 1984-04-01

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