BEUDAMED
    FDA Registration Active 🇺🇸 United States

    468405 SYNCHRON Systems CAL 1 Calibrator 1

    Reg #: 2050010 · FEI: 2050010 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    2050010
    FEI Number
    2050010
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2470 Faraday Ave
    City
    CARLSBAD
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032035

    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
    Complement C4, Antigen, Antiserum, Control DBI
    Complement C3, Antigen, Antiserum, Control CZW

    Proprietary Names

    468405 SYNCHRON Systems CAL 1 Calibrator 1 988471 C4 Reagent (C4 2 x 100) 988462 C3 Reagent (C3 2 x 100)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)