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

    ALKALINE PHOSPHATASE ISOYZME REAGENT SET

    K Number: K770155 · Decision Jan 31, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    11
    Review Days
    7

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    Basic Information

    Device Name
    ALKALINE PHOSPHATASE ISOYZME REAGENT SET
    K Number
    K770155
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gelman Instrument Co.
    Date Received
    January 24, 1977
    Decision Date
    January 31, 1977
    Product Code
    CJO
    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
    CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

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