BEUDAMED
    FDA Registration Active 🇨🇳 China

    DxFLEX Flow Cytometer

    Reg #: 3003244710 · FEI: 3003244710 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Beckman Coulter Biotechnology (Suzhou) Co., Ltd
    Registration Number
    3003244710
    FEI Number
    3003244710
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Units 101, 201, 301, Building 4 No. 218 Sangtian Street, BioBAY Sangtian Island, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232600

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    David G Davis

    US Agent

    Business Name
    BECKMAN COULTER, INC.
    Contact Name
    David Davis
    Address
    250 S Kraemer Blvd
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    469 2368180

    Products

    Device Name Product Code
    Flow Cytometric Test System For Hematopoietic Neoplasms PWD
    Flow Cytometric Reagents And Accessories. OYE

    Proprietary Names

    DxFLEX Flow Cytometer ClearLLab 10C T Cell Tube, ClearLLab 10C B Cell Tube, ClearLLab 10C M1 Cell Tube, ClearLLab M2 Cell Tube

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility