BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    IGX PLEX CELIAC QUALITATIVE ASSAY

    K Number: K102490 · Decision Jun 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    275

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    Basic Information

    Device Name
    IGX PLEX CELIAC QUALITATIVE ASSAY
    K Number
    K102490
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sqi Diagnostics Systems
    Date Received
    August 31, 2010
    Decision Date
    June 2, 2011
    Product Code
    MVM
    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
    MVM Autoantibodies, Endomysial(Tissue Transglutaminase)

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    Other Clearances by Sqi Diagnostics Systems

    K Number Device Name
    K083080 IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM