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

    ALKALINE PHOSPHATES ISOENZYME SUBSTRATE

    K Number: K830118 · Decision Feb 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    25
    Applicant Total
    111
    Review Days
    45

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    Basic Information

    Device Name
    ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
    K Number
    K830118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    January 11, 1983
    Decision Date
    February 25, 1983
    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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