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

    ALKALINE PHOSPHATASE ISOENZYME SYSTEM

    K Number: K885024 · Decision Feb 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    25
    Applicant Total
    125
    Review Days
    74

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    Basic Information

    Device Name
    ALKALINE PHOSPHATASE ISOENZYME SYSTEM
    K Number
    K885024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    December 5, 1988
    Decision Date
    February 17, 1989
    Product Code
    CIN
    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
    CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

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