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

    ANA-SCREEN WITH MDSS

    K Number: K113610 · Decision Jul 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    46
    Review Days
    216

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    Basic Information

    Device Name
    ANA-SCREEN WITH MDSS
    K Number
    K113610
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories
    Date Received
    December 6, 2011
    Decision Date
    July 9, 2012
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

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