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

    XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

    K Number: DEN070004 · Decision Mar 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    50
    Review Days
    4

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    Basic Information

    Device Name
    XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
    K Number
    DEN070004
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.3225
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Cepheid
    Date Received
    March 12, 2007
    Decision Date
    March 16, 2007
    Product Code
    OAI
    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
    OAI Assay, Enterovirus Nucleic Acid

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