BEUDAMED
    FDA Registration Active 🇺🇸 United States

    469975 CAL 5 PLUS Calibrator 5 Plus

    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
    K071002

    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, Multi-Analyte Mixture JIX
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD

    Proprietary Names

    469975 CAL 5 PLUS Calibrator 5 Plus A38656 IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent Part numbers include, but are not limited to Immage CCRP reagent Immage CAL 5 Plus

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility