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

    CREATINE KINASE (COLORIMETRIC METHOD)

    K Number: K880178 · Decision Feb 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    36
    Review Days
    34

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    Basic Information

    Device Name
    CREATINE KINASE (COLORIMETRIC METHOD)
    K Number
    K880178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Tech-Co, Inc.
    Date Received
    January 15, 1988
    Decision Date
    February 18, 1988
    Product Code
    JHY
    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
    JHY Colorimetric Method, Cpk Or Isoenzymes

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