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    FDA Registration Active 🇺🇸 United States

    Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application

    Reg #: 1061932 · FEI: 3000203293 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    1061932
    FEI Number
    3000203293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11800 SW 147TH AVE.
    City
    Miami
    State
    FL
    ZIP
    33196
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193124

    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

    Products

    Device Name Product Code
    Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment QFS
    Counter, Differential Cell GKZ

    Proprietary Names

    Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application Unicel DxH 800 Coulter Cellular Analysis System

    Establishment Types

    Manufacture Medical Device