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

    ANTINUCLEAR ANTIBODY TEST KIT

    K Number: K831927 · Decision Jul 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    33

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    Basic Information

    Device Name
    ANTINUCLEAR ANTIBODY TEST KIT
    K Number
    K831927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Breit Laboratories, Inc.
    Date Received
    June 15, 1983
    Decision Date
    July 18, 1983
    Product Code
    DAA
    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
    DAA Igg, Peroxidase, Antigen, Antiserum, Control

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