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

    CK-MB(IMMUNOLOGICAL)

    K Number: K802521 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    21
    Review Days
    28

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    Basic Information

    Device Name
    CK-MB(IMMUNOLOGICAL)
    K Number
    K802521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biodynamics Corp.
    Date Received
    October 15, 1980
    Decision Date
    November 12, 1980
    Product Code
    JHS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

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