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

    LACTATE DEHYDROGENASE ISOENZYME 1

    K Number: K872891 · Decision Sep 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    111
    Review Days
    55

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    Basic Information

    Device Name
    LACTATE DEHYDROGENASE ISOENZYME 1
    K Number
    K872891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Data Medical Associates, Inc.
    Date Received
    July 23, 1987
    Decision Date
    September 16, 1987
    Product Code
    CEX
    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
    CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

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