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

    cobas CTNG for use on cobas 6800/8800 systems

    K Number: K202408 · Decision Jan 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    22
    Applicant Total
    51
    Review Days
    153

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    Basic Information

    Device Name
    cobas CTNG for use on cobas 6800/8800 systems
    K Number
    K202408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3393
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    August 21, 2020
    Decision Date
    January 21, 2021
    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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