BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SOFIA INFLUENZA A+B FIA

    K Number: K131606 · Decision Jul 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    93
    Review Days
    32

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    Basic Information

    Device Name
    SOFIA INFLUENZA A+B FIA
    K Number
    K131606
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Corp.
    Date Received
    June 3, 2013
    Decision Date
    July 5, 2013
    Product Code
    GNX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

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