BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇷 Argentina

    WIENER LAB GOT (AST) UV AA LIQUIDA

    K Number: K023551 · Decision Dec 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    138
    Applicant Total
    24
    Review Days
    48

    Basic Information

    Device Name
    WIENER LAB GOT (AST) UV AA LIQUIDA
    K Number
    K023551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WIENER LABORATORIES S.A.I.C.
    Date Received
    October 22, 2002
    Decision Date
    December 9, 2002
    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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