Beckman Coulter Biomedical G M B H

FDA Filings

This page includes the latest FDA filings for Beckman Coulter Biomedical G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006677029
• FEI Number: 3006677029
• Name: Beckman Coulter Biomedical GmbH
• Owner & Operator: BECKMAN COULTER, INC.
• Contact Address: 250 S. Kraemer Blvd --; Brea CA 92821 US
• Official Correspondent:
  • David G Davis
  • x-469-2368180-x
• US Agent:
  • Dave G. Davis
  • 469 2368180
  • dgdavis@beckman.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Sauerbruchstr. 50 ; Munchen Bayern, 81377 DE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K190298 | JMG Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	DxA 5000	2019-10-30
PMN K190298 | JLW Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	DxA 5000	2019-10-30
PMN K190298 | JJE Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	DxA 5000	2019-10-30
PMN K190298 | CGN Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	DxA 5000	2019-10-30
PMN K190298 | CDD Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	DxA 5000	2019-10-30
PMN K190298 Beckman Coulter Biomedical GmbH	DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12	2019-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	ODL25255 AutoMate 2550 LAB INSTRUMENT	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	ODL25250 AutoMate 2500 LAB INSTRUMENT	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	ODL25125 AutoMate 1250 LAB INSTRUMENT	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	ODL25120 AutoMate 1200 LAB INSTRUMENT	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C Single User 1 Year Educational License (PN C10579)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C Single Use 1 Year License (PN C10575)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C Perpetual License (PN C10574)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C Perpetual Education License (PN C10578)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C Flow Cytometry Software (PN C21166)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C 5 User Network Educational License (PN C10581)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C 5 User Network (PN C10577)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C 10 User Network Educational License (PN C10580)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Kaluza C 10 User Network (PN C10576)	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	DxOne Workflow Manager	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	Command Central	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	AutoMate 2550 Sample Processing System	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	AutoMate 2500 Sample Processing System	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	AutoMate 1250 Sample Processing System	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	AutoMate 1200 Sample Processing System	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	A18896 Automate 600 Sample Processing System	2000-10-04
JQP Beckman Coulter Biomedical GmbH [BECKMAN COULTER, INC.]	A18894 Automate 800 Sample Processing System	2000-10-04