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

    GLIADIN IGA AND GLIADIN LGA

    K Number: K113377 · Decision Dec 14, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    394

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    Basic Information

    Device Name
    GLIADIN IGA AND GLIADIN LGA
    K Number
    K113377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grifols USA, LLC
    Date Received
    November 16, 2011
    Decision Date
    December 14, 2012
    Product Code
    MST
    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
    MST Antibodies, Gliadin

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