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510(k) Data Aggregation

    K Number
    K243822
    Device Name
    BioFire Warrior Panel; BioFire Warrior Panel Control Kit
    Manufacturer
    BioFire Defense, LLC
    Date Cleared
    2025-03-12

    (90 days)

    Product Code
    PRD
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    PRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K170883
    Device Name
    FilmArray NGDS Warrior Panel
    Manufacturer
    BioFire Defense, LLC
    Date Cleared
    2017-06-22

    (90 days)

    Product Code
    PRD
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    PRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    DEN160048
    Device Name
    FilmArray NGDS Warrior Panel
    Manufacturer
    BioFire Defense, LLC
    Date Cleared
    2017-02-14

    (120 days)

    Product Code
    PRD
    Regulation Number
    N/A
    Type
    Direct
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    PRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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