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

    TRANSPHOR TM LD LACTATE DEHYDROGENASE

    K Number: K800568 · Decision Apr 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    27
    Applicant Total
    111
    Review Days
    22

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    Basic Information

    Device Name
    TRANSPHOR TM LD LACTATE DEHYDROGENASE
    K Number
    K800568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    March 13, 1980
    Decision Date
    April 4, 1980
    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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