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

    BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System

    K Number: K250358 · Decision Oct 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    134
    Review Days
    266

    Basic Information

    Device Name
    BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
    K Number
    K250358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    February 7, 2025
    Decision Date
    October 31, 2025
    Product Code
    PCI
    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
    PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

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