BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Unyvero LRT BAL Application

    K Number: K191967 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    150

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    Basic Information

    Device Name
    Unyvero LRT BAL Application
    K Number
    K191967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3985
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curetis GmbH
    Date Received
    July 23, 2019
    Decision Date
    December 20, 2019
    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.

    Curetis Unyvero LRT Application

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Curetis GmbH

    K Number Device Name
    DEN170047 Curetis Unyvero LRT Application