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

    CREATINE KINASE ISOENZYME SUBSTRATE SET

    K Number: K771605 · Decision Sep 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    24

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    Basic Information

    Device Name
    CREATINE KINASE ISOENZYME SUBSTRATE SET
    K Number
    K771605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pfizer Pharmaceuticals
    Date Received
    August 22, 1977
    Decision Date
    September 15, 1977
    Product Code
    JHX
    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
    JHX Fluorometric Method, Cpk Or Isoenzymes

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