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

    XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)

    K Number: K120911 · Decision May 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    50
    Review Days
    53

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    Basic Information

    Device Name
    XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
    K Number
    K120911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3332
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cepheid
    Date Received
    March 26, 2012
    Decision Date
    May 18, 2012
    Product Code
    OQW
    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
    OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

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