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

    BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

    K Number: K243544 · Decision Aug 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    32
    Applicant Total
    28
    Review Days
    272

    Basic Information

    Device Name
    BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
    K Number
    K243544
    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, LLC
    Date Received
    November 15, 2024
    Decision Date
    August 14, 2025
    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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