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

    CREATINE KINASE (CK) ISOENZYME MB

    K Number: K881168 · Decision Nov 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    20
    Applicant Total
    111
    Review Days
    237

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    Basic Information

    Device Name
    CREATINE KINASE (CK) ISOENZYME MB
    K Number
    K881168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Data Medical Associates, Inc.
    Date Received
    March 18, 1988
    Decision Date
    November 10, 1988
    Product Code
    JHT
    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
    JHT Chromatographic Separation, Cpk Isoenzymes

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