BEUDAMED
    FDA Registration Active 🇺🇸 United States

    B23634 UniCel DxC SYNCHRON Systems HDL Calibrator

    Reg #: 2050012 · FEI: 2050012 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    2050012
    FEI Number
    2050012
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    250 S Kraemer Blvd
    City
    BREA
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142985

    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
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Calibrator, Secondary JIT

    Proprietary Names

    B23634 UniCel DxC SYNCHRON Systems HDL Calibrator A15625 HDL Cholesterol Reagent HDL 2 x 200

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility