BEUDAMED
    FDA Registration Active 🇺🇸 United States

    467910 Iron Reagent (FE 2 x 200)

    Reg #: 2050012 · FEI: 2050012 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    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
    K960485

    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
    Calibrator, Secondary JIT
    Ferrozine (Colorimetric) Iron Binding Capacity JMO

    Proprietary Names

    467910 Iron Reagent (FE 2 x 200) 465970 Total Iron Binding Capacity Reagent (IBCT 2 x 100) 465971 Total Iron Binding Capacity Reagent (IBCT 2 x 100) 465976 SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit 442772 SYNCHRON Systems FE/IBCT Calibrator Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility