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

    ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer

    K Number: K183592 · Decision Mar 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
    K Number
    K183592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7010
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter
    Date Received
    December 21, 2018
    Decision Date
    March 21, 2019
    Product Code
    PWD
    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
    PWD Flow Cytometric Test System For Hematopoietic Neoplasms

    Similar 510(k) Clearances

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

    ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Beckman Coulter

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    K181475 DxH 520 Hematology Instrument
    DEN160047 ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
    K162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser