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

    BIOFIRE FILMARRAY Tropical Fever Panel

    K Number: K243463 · Decision Dec 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    BIOFIRE FILMARRAY Tropical Fever Panel
    K Number
    K243463
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3966
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Diagnostics, LLC (Biomerieux)
    Date Received
    November 8, 2024
    Decision Date
    December 5, 2024
    Product Code
    QMV
    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
    QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QMV), ordered by most recent decision date.

    BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray Global Fever Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology
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    Other Clearances by Biofire Diagnostics, LLC (Biomerieux)

    K Number Device Name
    K243222 BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)