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

    Panther Fusion GI Expanded Bacterial Assay

    K Number: K251993 · Decision Sep 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    37
    Applicant Total
    116
    Review Days
    90

    Basic Information

    Device Name
    Panther Fusion GI Expanded Bacterial Assay
    K Number
    K251993
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic, Inc.
    Date Received
    June 27, 2025
    Decision Date
    September 25, 2025
    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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