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

    ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK

    K Number: K832357 · Decision Sep 1, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    233
    Applicant Total
    253
    Review Days
    45

    Basic Information

    Device Name
    ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK
    K Number
    K832357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. DUPONT DE NEMOURS & CO., INC.
    Date Received
    July 18, 1983
    Decision Date
    September 1, 1983
    Product Code
    CIG
    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
    CIG Diazo Colorimetry, Bilirubin

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