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

    ANTI-N DNA ANTIBODY TEST KIT

    K Number: K832031 · Decision Aug 11, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    49

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    Basic Information

    Device Name
    ANTI-N DNA ANTIBODY TEST KIT
    K Number
    K832031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Breit Laboratories, Inc.
    Date Received
    June 23, 1983
    Decision Date
    August 11, 1983
    Product Code
    KTL
    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
    KTL Anti-Dna Indirect Immunofluorescent Solid Phase

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    Other Clearances by Breit Laboratories, Inc.

    K Number Device Name
    K851099 IGM RHEUMATOID FACTOR TEST KIT
    K842137 OCCULT BLOOD TEST
    K840527 COLOTRAK OCCULT BLOOD TEST
    K831927 ANTINUCLEAR ANTIBODY TEST KIT