BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    B86446 DxC 700 AU for Direct Track Sampling with ISE

    Reg #: 3008244372 · FEI: 3008244372 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Beckman Coulter K. K.
    Registration Number
    3008244372
    FEI Number
    3008244372
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    454-32 Higashino, Nagaizumi-Cho
    City
    Sunto-Gun Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K161837

    Owner / Operator

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

    Products

    Device Name Product Code
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion-Specific, Chloride CGZ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion Specific, Sodium JGS

    Proprietary Names

    B86446 DxC 700 AU for Direct Track Sampling with ISE B86444 DxC 700 AU with ISE B86445 DxC 700 AU for Direct Track Sampling B86443 DxC 700 AU

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility