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

    ANTI N DNA-HCP

    K Number: K830652 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    12
    Review Days
    17

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    Basic Information

    Device Name
    ANTI N DNA-HCP
    K Number
    K830652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Immuno-Products Industries
    Date Received
    March 7, 1983
    Decision Date
    March 24, 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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