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

    BioFire Warrior Panel; BioFire Warrior Panel Control Kit

    K Number: K243822 · Decision Mar 12, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    BioFire Warrior Panel; BioFire Warrior Panel Control Kit
    K Number
    K243822
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Defense, LLC
    Date Received
    December 12, 2024
    Decision Date
    March 12, 2025
    Product Code
    PRD
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

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