BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

    Reg #: 9680746 · FEI: 1000206808 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Beckman Coulter Ireland Inc
    Registration Number
    9680746
    FEI Number
    1000206808
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LISMEEHAN
    City
    O CALLAGHANS MILLS Clare
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K000121

    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
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Calibrator, Primary JIS

    Proprietary Names

    465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 447450 IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)