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

    VARELISA RECOMBI ANA SCREEN, MODEL 12 596

    K Number: K083188 · Decision Mar 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    111
    Applicant Total
    22
    Review Days
    135

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    Basic Information

    Device Name
    VARELISA RECOMBI ANA SCREEN, MODEL 12 596
    K Number
    K083188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    October 29, 2008
    Decision Date
    March 13, 2009
    Product Code
    LJM
    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
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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