BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GOT ISOENZYME ASSAY EIKEN KIT

    K Number: K802447 · Decision Apr 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    138
    Applicant Total
    34
    Review Days
    191

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    Basic Information

    Device Name
    GOT ISOENZYME ASSAY EIKEN KIT
    K Number
    K802447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Syn-Kit, Inc.
    Date Received
    October 8, 1980
    Decision Date
    April 17, 1981
    Product Code
    CIT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

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