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

    cobas liat Bordetella panel nucleic acid test

    K Number: K243753 · Decision Nov 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    51
    Review Days
    350

    Basic Information

    Device Name
    cobas liat Bordetella panel nucleic acid test
    K Number
    K243753
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    December 5, 2024
    Decision Date
    November 20, 2025
    Product Code
    OZZ
    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
    OZZ Bordetella Pertussis Dna Assay System

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