BEUDAMED
    FDA Registration Active 🇮🇳 India

    DxFLEX Flow Cytometer

    Reg #: 3016954941 · FEI: 3016954941 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Beckman Coulter India Private Limited
    Registration Number
    3016954941
    FEI Number
    3016954941
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot No 37/1 Hitech/Defence Aerospace, IT Sector Mahadevakodigehalli Village, Hobli Jala Taluk, Bangalore North
    City
    Bengaluru (Bangalore) Urban Karnataka
    Country
    IN

    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

    Manufacture Medical Device