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

    ALKALINE PHOSPHATASE ISOENZY. SUB. SET

    K Number: K771620 · Decision Sep 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    25
    Applicant Total
    30
    Review Days
    21

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    Basic Information

    Device Name
    ALKALINE PHOSPHATASE ISOENZY. SUB. SET
    K Number
    K771620
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pfizer, Inc.
    Date Received
    August 25, 1977
    Decision Date
    September 15, 1977
    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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