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

    QUANTA FLASH H-TTG IGG

    K Number: K101644 · Decision Mar 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    39
    Applicant Total
    126
    Review Days
    286

    Basic Information

    Device Name
    QUANTA FLASH H-TTG IGG
    K Number
    K101644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    INOVA DIAGNOSTICS, INC.
    Date Received
    June 10, 2010
    Decision Date
    March 23, 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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