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

    ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER

    K Number: K944192 · Decision Mar 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    19
    Review Days
    189

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    Basic Information

    Device Name
    ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER
    K Number
    K944192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Diagnostics
    Date Received
    August 29, 1994
    Decision Date
    March 6, 1995
    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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