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

    IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G

    K Number: K013432 · Decision Nov 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    36
    Review Days
    45

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    Basic Information

    Device Name
    IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
    K Number
    K013432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immuno Concepts, Inc.
    Date Received
    October 15, 2001
    Decision Date
    November 29, 2001
    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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