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

    QUANTA LITE F-ACTIN IGA ELISA

    K Number: K072967 · Decision Jan 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    39
    Applicant Total
    138
    Review Days
    98

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    Basic Information

    Device Name
    QUANTA LITE F-ACTIN IGA ELISA
    K Number
    K072967
    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
    October 22, 2007
    Decision Date
    January 28, 2008
    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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