Beckman Coulter Laboratory Systems Suzhou Co L T D

FDA Filings

This page includes the latest FDA filings for Beckman Coulter Laboratory Systems Suzhou Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003244710
FEI Number3003244710
NameBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Owner & OperatorBECKMAN COULTER, INC.
Contact Address250 S. Kraemer Blvd --
Brea CA 92821 US
Official Correspondent
  • David G Davis
  • x-469-2368180-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo. 181 West Su Hong Road Suzhou Industrial Park
Suzhou Jiangsu, 215021 CN
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. [BECKMAN COULTER, INC.]
Access Sensitive Estradiol Calibrators PN B844942018-02-02
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. [BECKMAN COULTER, INC.]
Access Sensitive Estradiol Calibrator S0 - PN B971452018-02-02
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. [BECKMAN COULTER, INC.]
Access C-Peptide Calibrators2018-02-02
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. [BECKMAN COULTER, INC.]
A15445 IMMAGE 8002013-02-08
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. [BECKMAN COULTER, INC.]
A15445 IMMAGE 8002013-02-08
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. [BECKMAN COULTER, INC.]
Access C-Peptide1999-04-28

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