BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Beckman Coulter K. K.

    Reg #: 3008244372 · FEI: 3008244372 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Beckman Coulter K. K.
    Registration Number
    3008244372
    FEI Number
    3008244372
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    454-32 Higashino, Nagaizumi-Cho
    City
    Sunto-Gun Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    BK180292

    Owner / Operator

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

    US Agent

    Business Name
    Beckman Coulter, Inc.
    Contact Name
    Ian Pilcher
    Address
    1000 Lake Hazeltine Dr
    City
    Chaska
    State
    MN
    ZIP
    55318
    Country
    US
    Email
    [email protected]
    Phone
    443 3506459

    Products

    Device Name Product Code
    System, Test, Automated Blood Grouping And Antibody KSZ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Sodium JGS

    Proprietary Names

    PK7400 Automated Microplate System PK7400 AU Beckman Coulter Chemistry Analyzers Beckman Coulter Chemistry Analyzer AU480 Beckman Coulter Chemistry Analyzer AU680 Beckman Coulter Chemistry Analyzer AU5800 B86444 DxC 700 AU with ISE B86446 DxC 700 AU for Direct Track Sampling 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