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

    BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

    K Number: K243222 · Decision Nov 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
    K Number
    K243222
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.4001
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Diagnostics, LLC (Biomerieux)
    Date Received
    October 7, 2024
    Decision Date
    November 6, 2024
    Product Code
    QDS
    Advisory Committee
    Pathology
    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
    QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

    Similar 510(k) Clearances

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

    FilmArray Pneumonia Panel plus

    FDA 510(k)
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    FilmArray Pneumonia Panel plus

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

    K Number Device Name
    K243463 BIOFIRE FILMARRAY Tropical Fever Panel