BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DYNAZYME II GPT 340

    K Number: K771152 · Decision Nov 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    126
    Applicant Total
    54
    Review Days
    129

    Basic Information

    Device Name
    DYNAZYME II GPT 340
    K Number
    K771152
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J.T. BAKER CHEMICAL CO.
    Date Received
    June 27, 1977
    Decision Date
    November 3, 1977
    Product Code
    CKA
    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
    CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

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