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

    CARDIOZYME PLUS CK-MB ITEM #65045

    K Number: K811573 · Decision Jun 25, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    116
    Review Days
    21

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    Basic Information

    Device Name
    CARDIOZYME PLUS CK-MB ITEM #65045
    K Number
    K811573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Harleco
    Date Received
    June 4, 1981
    Decision Date
    June 25, 1981
    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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    Other Clearances by Harleco

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    K813040 ULTRACHEM CA, ITEM #64975
    K813044 ULTRACHEM ALB, ITEM #64970
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