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

    FilmArray Meningitis/Encephalitis(ME) Panel

    K Number: DEN150013 · Decision Oct 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    28
    Review Days
    182

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    Basic Information

    Device Name
    FilmArray Meningitis/Encephalitis(ME) Panel
    K Number
    DEN150013
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3970
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Biofire Diagnostics, LLC
    Date Received
    April 9, 2015
    Decision Date
    October 8, 2015
    Product Code
    PLO
    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
    PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

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