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

    BIOFIRE SPOTFIRE Respiratory (R) Panel

    K Number: K213954 · Decision Feb 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    413

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    Basic Information

    Device Name
    BIOFIRE SPOTFIRE Respiratory (R) Panel
    K Number
    K213954
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Diagnostics
    Date Received
    December 17, 2021
    Decision Date
    February 3, 2023
    Product Code
    QOF
    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
    QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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    Other Clearances by Biofire Diagnostics

    K Number Device Name
    K140407 FILMARRAY GASTROINTESTINAL (GI) PANEL