BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Beckman Coulter Lyophilized Chemistry Calibrator 1 and 2

    Reg #: 2016706 · FEI: 2016706 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bio-Rad Laboratories Inc.
    Registration Number
    2016706
    FEI Number
    2016706
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9500 Jeronimo Rd
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043460

    Owner / Operator

    Firm Name
    Bio-Rad Laboratories, Inc.
    Operator Number
    9929003
    Address
    4000 Alfred Nobel Drive, --
    City
    Hercules
    State
    CA
    Postal Code
    94547
    Country
    US

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    Beckman Coulter Lyophilized Chemistry Calibrator 1 and 2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)