BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2

    Reg #: 2050010 · FEI: 2050010 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    13

    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
    K965240

    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
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Electrode, Ion Specific, Urea Nitrogen CDS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion-Specific, Chloride CGZ
    Calibrator, Multi-Analyte Mixture JIX
    Bromcresol Green Dye-Binding, Albumin CIX
    Electrode, Ion Specific, Sodium JGS
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Potassium CEM
    Ph Rate Measurement, Carbon-Dioxide JFL
    Biuret (Colorimetric), Total Protein CEK
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Electrode, Ion Specific, Calcium JFP

    Proprietary Names

    SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2 Glucose Oxygen Sensor BUN Electrode NA+ Electrode CO2 Electrode Chloride Electrode Calcium Electrode Potassium Electrode

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)