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

    MALDI Biotyper CA System

    K Number: K142677 · Decision Mar 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    189

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    Basic Information

    Device Name
    MALDI Biotyper CA System
    K Number
    K142677
    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
    September 19, 2014
    Decision Date
    March 27, 2015
    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

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

    MALDI Biotyper CA (MBT-CA) System, MBT smart CA System

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    FDA Class 2 ·Microbiology

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    MALDI BIOTYPER CA (MBT-CA) SYSTEM

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    FDA Class 2 ·Microbiology

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    Other Clearances by Bruker Daltonics, Inc.

    K Number Device Name
    K130831 MALDI BIOTYPER CA (MBT-CA) SYSTEM