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

    CREATINE PHOSPHOKINASE (CPK) REAGENT SET

    K Number: K792533 · Decision Jan 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    23
    Review Days
    35

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    Basic Information

    Device Name
    CREATINE PHOSPHOKINASE (CPK) REAGENT SET
    K Number
    K792533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Macomb Chemical Co.
    Date Received
    December 7, 1979
    Decision Date
    January 11, 1980
    Product Code
    JHW
    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
    JHW U.V. Method, Cpk Isoenzymes

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