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

    LDH CLINI GEL KIT

    K Number: K791827 · Decision Oct 1, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    27
    Applicant Total
    30
    Review Days
    14

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    Basic Information

    Device Name
    LDH CLINI GEL KIT
    K Number
    K791827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Clinical Sciences, Inc.
    Date Received
    September 17, 1979
    Decision Date
    October 1, 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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