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

    MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT

    K Number: K902237 · Decision Jul 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    47
    Review Days
    52

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    Basic Information

    Device Name
    MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT
    K Number
    K902237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Medica Corp.
    Date Received
    May 18, 1990
    Decision Date
    July 9, 1990
    Product Code
    DBL
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

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