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

    FilmArray Global Fever Panel External Control Kit

    K Number: K202382 · Decision Nov 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    30
    Applicant Total
    9
    Review Days
    92

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    Basic Information

    Device Name
    FilmArray Global Fever Panel External Control Kit
    K Number
    K202382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3920
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Defense, LLC
    Date Received
    August 20, 2020
    Decision Date
    November 20, 2020
    Product Code
    PMN
    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
    PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

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    Other Clearances by Biofire Defense, LLC

    K Number Device Name
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    K220870 BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
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    DEN200043 FilmArray Global Fever Panel
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