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

    cobas liat CT/NG nucleic acid test

    K Number: K253756 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    22
    Applicant Total
    51
    Review Days
    171

    Basic Information

    Device Name
    cobas liat CT/NG nucleic acid test
    K Number
    K253756
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3393
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    November 25, 2025
    Decision Date
    May 15, 2026
    Product Code
    QEP
    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
    QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

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