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

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

    K Number: K242367 · Decision Nov 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    37
    Applicant Total
    28
    Review Days
    90

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    Basic Information

    Device Name
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
    K Number
    K242367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Diagnostics, LLC
    Date Received
    August 9, 2024
    Decision Date
    November 7, 2024
    Product Code
    PCH
    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
    PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

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