BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DISTAT ANTI-DSDNA KIT

    K Number: K905386 · Decision Dec 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    27
    Review Days
    13

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    Basic Information

    Device Name
    DISTAT ANTI-DSDNA KIT
    K Number
    K905386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Shield Diagnostics, Ltd.
    Date Received
    November 30, 1990
    Decision Date
    December 13, 1990
    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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