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

    ANTINUCLEAR ANTIBODY TEST KIT

    K Number: K851369 · Decision May 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    5
    Review Days
    40

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    Basic Information

    Device Name
    ANTINUCLEAR ANTIBODY TEST KIT
    K Number
    K851369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Modern Diagnostics, Inc.
    Date Received
    April 5, 1985
    Decision Date
    May 15, 1985
    Product Code
    DHN
    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
    DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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    Other Clearances by Modern Diagnostics, Inc.

    K Number Device Name
    K853269 PREGNA/TEST
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