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

    COLORIMETRIC DETERMINATION (SGOT/SGPT)

    K Number: K760010 · Decision Jul 26, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    138
    Applicant Total
    26
    Review Days
    46

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    Basic Information

    Device Name
    COLORIMETRIC DETERMINATION (SGOT/SGPT)
    K Number
    K760010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The Dow Chemical Co.
    Date Received
    June 10, 1976
    Decision Date
    July 26, 1976
    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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