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

    cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems

    K Number: K243455 · Decision Jul 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    32
    Applicant Total
    51
    Review Days
    266

    Basic Information

    Device Name
    cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
    K Number
    K243455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    November 7, 2024
    Decision Date
    July 31, 2025
    Product Code
    QOF
    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
    QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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