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

    DYNAZYME TM II CARDIAK-MB

    K Number: K772172 · Decision Dec 6, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    54
    Review Days
    15

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    Basic Information

    Device Name
    DYNAZYME TM II CARDIAK-MB
    K Number
    K772172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    November 21, 1977
    Decision Date
    December 6, 1977
    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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