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

    cobas vivoDx MRSA

    K Number: DEN190016 · Decision Dec 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    51
    Review Days
    261

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    Basic Information

    Device Name
    cobas vivoDx MRSA
    K Number
    DEN190016
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.1655
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    March 19, 2019
    Decision Date
    December 5, 2019
    Product Code
    QIV
    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
    QIV Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

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