BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XP-300

    Reg #: 3020704087 · FEI: 3020704087 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sysmex America, Inc. - Vernon Hills
    Registration Number
    3020704087
    FEI Number
    3020704087
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1011 Woodlands Parkway
    City
    Vernon Hills
    State
    IL
    ZIP
    60061
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981761

    Owner / Operator

    Firm Name
    SYSMEX CORPORATION
    Operator Number
    9014170
    Address
    4-4-4 TAKATSUKADAI, NISHI-KU
    City
    KOBE
    State
    JP-NOTA
    Postal Code
    651-2271
    Country
    JP

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ
    Counter, Cell, Automated (Particle Counter) GKL

    Proprietary Names

    XP-300

    Establishment Types

    Manufacture Medical Device