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

    ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD

    K Number: K921455 · Decision Apr 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    27
    Applicant Total
    253
    Review Days
    33

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    Basic Information

    Device Name
    ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
    K Number
    K921455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    March 27, 1992
    Decision Date
    April 29, 1992
    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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