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    FDA Registration Active 🇨🇳 China

    BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

    Reg #: 3027977508 · FEI: 3027977508 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    4

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    Registration Details

    Registration Name
    BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
    Registration Number
    3027977508
    FEI Number
    3027977508
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.11, Zhensheng Road, Suzhou Industrial Park, Area 1, 1st Floor, Building 4; Area 1, Building 3; Area 1, Building 2
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K220977

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US

    US Agent

    Business Name
    Beckman Coulter, Inc.
    Contact Name
    Ian Pilcher
    Address
    1000 Lake Hazeltine Dr
    City
    Chaska
    State
    MN
    ZIP
    55318
    Country
    US
    Email
    [email protected]
    Phone
    443 3506459

    Products

    Device Name Product Code
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Calibrator, Secondary JIT
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Nephelometer, For Clinical Use JQX

    Proprietary Names

    Access C-Peptide (P/N: C33451) Access Sensitive Estradiol Calibrator S0 (P/N: B97145) Access Sensitive Estradiol Calibrators (P/N: B84494) Access C-Peptide Calibrators (P/N: C31860) Access Syphilis Calibrators (P/N: C80412 MFG-BioRad) DxC 500 AU Clinical Chemistry Analyzer A15445 IMMAGE 800

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)