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

    cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

    K Number: K231306 · Decision Jun 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    51
    Review Days
    27

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    Basic Information

    Device Name
    cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
    K Number
    K231306
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    May 5, 2023
    Decision Date
    June 1, 2023
    Product Code
    QQX
    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
    QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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