BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇩🇪 Germany

    Curetis Unyvero LRT Application

    K Number: DEN170047 · Decision Apr 3, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    204

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    Basic Information

    Device Name
    Curetis Unyvero LRT Application
    K Number
    DEN170047
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3985
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Curetis GmbH
    Date Received
    September 11, 2017
    Decision Date
    April 3, 2018
    Product Code
    QBH
    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
    QBH Lower Respiratory Microbial Nucleic Acid Detection System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QBH), ordered by most recent decision date.

    Unyvero LRT BAL Application

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    Other Clearances by Curetis GmbH

    K Number Device Name
    K191967 Unyvero LRT BAL Application