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

    MALDI BIOTYPER CA (MBT-CA) SYSTEM

    K Number: K130831 · Decision Nov 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    240

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    Basic Information

    Device Name
    MALDI BIOTYPER CA (MBT-CA) SYSTEM
    K Number
    K130831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3361
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bruker Daltonics, Inc.
    Date Received
    March 26, 2013
    Decision Date
    November 21, 2013
    Product Code
    PEX
    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
    PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

    Similar 510(k) Clearances

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    FDA Class 2 ·Microbiology

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    Other Clearances by Bruker Daltonics, Inc.

    K Number Device Name
    K142677 MALDI Biotyper CA System