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

    COLORIMETRIC LDH REAGENT SET

    K Number: K820768 · Decision Apr 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    11
    Review Days
    23

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    Basic Information

    Device Name
    COLORIMETRIC LDH REAGENT SET
    K Number
    K820768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1440
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biorent Diagnostic, Inc.
    Date Received
    March 22, 1982
    Decision Date
    April 14, 1982
    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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