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

    ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS

    K Number: K791373 · Decision Oct 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    27
    Applicant Total
    49
    Review Days
    94

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    Basic Information

    Device Name
    ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
    K Number
    K791373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    July 24, 1979
    Decision Date
    October 26, 1979
    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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