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

    FilmArray NGDS Warrior Panel

    K Number: K170883 · Decision Jun 22, 2017
    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
    FilmArray NGDS Warrior Panel
    K Number
    K170883
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Defense, LLC
    Date Received
    March 24, 2017
    Decision Date
    June 22, 2017
    Product Code
    PRD
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

    Similar 510(k) Clearances

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    BioFire Warrior Panel; BioFire Warrior Panel Control Kit

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    FilmArray NGDS Warrior Panel

    FDA 510(k)

    Other Clearances by Biofire Defense, LLC

    K Number Device Name
    K243822 BioFire Warrior Panel; BioFire Warrior Panel Control Kit
    K213362 BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
    K220870 BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
    K221460 BioFire COVID-19 Test 2
    K211079 BioFire COVID-19 Test 2
    K202382 FilmArray Global Fever Panel External Control Kit
    DEN200043 FilmArray Global Fever Panel
    DEN160048 FilmArray NGDS Warrior Panel