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

    ANTI NDNA IMMUNOFLOURESCENT TEST SYS

    K Number: K810981 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    12
    Review Days
    16

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    Basic Information

    Device Name
    ANTI NDNA IMMUNOFLOURESCENT TEST SYS
    K Number
    K810981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5820
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Immuno-Products Industries
    Date Received
    April 13, 1981
    Decision Date
    April 29, 1981
    Product Code
    DHC
    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
    DHC System, Test, Systemic Lupus Erythematosus

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