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

    SPIN CHEM REAGENT, DETERMINATION OF AST

    K Number: K791082 · Decision Jul 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    138
    Applicant Total
    41
    Review Days
    35

    Basic Information

    Device Name
    SPIN CHEM REAGENT, DETERMINATION OF AST
    K Number
    K791082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    SMITH KLINE DIAGNOSTICS, INC.
    Date Received
    June 12, 1979
    Decision Date
    July 17, 1979
    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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