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

    LDH REAGENT SET

    K Number: K812836 · Decision Oct 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    26
    Review Days
    —

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    Basic Information

    Device Name
    LDH REAGENT SET
    K Number
    K812836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1440
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Anco Medical Reagents & Assoc.
    Date Received
    October 9, 1981
    Decision Date
    October 9, 1981
    Product Code
    CFH
    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
    CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

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