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

    LUPO-TEC

    K Number: K782129 · Decision Mar 12, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    68
    Review Days
    75

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    Basic Information

    Device Name
    LUPO-TEC
    K Number
    K782129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5820
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Armkel, LLC
    Date Received
    December 27, 1978
    Decision Date
    March 12, 1979
    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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