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

    MBT Compass HT CA Software; MBT FAST Shuttle US IVD

    K Number: K251495 · Decision Aug 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    90

    Basic Information

    Device Name
    MBT Compass HT CA Software; MBT FAST Shuttle US IVD
    K Number
    K251495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3378
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bruker Daltonics GmbH & Co. KG
    Date Received
    May 15, 2025
    Decision Date
    August 13, 2025
    Product Code
    QBN
    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
    QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

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