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

    CODE QAS 103 ANTI-DNA CONTROLS

    K Number: K791354 · Decision Sep 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    94
    Review Days
    61

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    Basic Information

    Device Name
    CODE QAS 103 ANTI-DNA CONTROLS
    K Number
    K791354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Amersham Corp.
    Date Received
    July 18, 1979
    Decision Date
    September 17, 1979
    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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