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

    MBT Sepsityper

    K Number: K193419 · Decision Dec 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    384

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    Basic Information

    Device Name
    MBT Sepsityper
    K Number
    K193419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3378
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bruker Daltonik GmbH
    Date Received
    December 9, 2019
    Decision Date
    December 27, 2020
    Product Code
    QNJ
    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
    QNJ Mass Spectrometry, Microorganism Identification, Blood Culture

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