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

    Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser

    K Number: K162897 · Decision Jun 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    249

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    Basic Information

    Device Name
    Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
    K Number
    K162897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter
    Date Received
    October 17, 2016
    Decision Date
    June 23, 2017
    Product Code
    OYE
    Advisory Committee
    Hematology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OYE Flow Cytometric Reagents And Accessories.

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    Other Clearances by Beckman Coulter

    K Number Device Name
    K232904 Access Ostase
    K193124 Unicel DxH 800 Coulter Cellular Analysis System
    K182886 Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
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    K181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
    K181475 DxH 520 Hematology Instrument
    DEN160047 ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M