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

    CARDIZYME PLUS LD #65094/93

    K Number: K832314 · Decision Sep 1, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    49

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    Basic Information

    Device Name
    CARDIZYME PLUS LD #65094/93
    K Number
    K832314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Industries, Inc.
    Date Received
    July 14, 1983
    Decision Date
    September 1, 1983
    Product Code
    CFE
    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
    CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

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    Other Clearances by Em Industries, Inc.

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    K823756 ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082