BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PK7400

    Reg #: 9612296 · FEI: 3002807663 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Beckman Coulter Mishima K.K.
    Registration Number
    9612296
    FEI Number
    3002807663
    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
    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

    Products

    Device Name Product Code
    System, Test, Automated Blood Grouping And Antibody KSZ

    Proprietary Names

    PK7400 PK7400 Automated Microplate System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)