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

    Creatine Kinase-MB

    K Number: K162526 · Decision May 26, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    183
    Review Days
    259

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    Basic Information

    Device Name
    Creatine Kinase-MB
    K Number
    K162526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics
    Date Received
    September 9, 2016
    Decision Date
    May 26, 2017
    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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