Ortho Clinical Diagnostics European Support Center

FDA Filings

This page includes the latest FDA filings for Ortho Clinical Diagnostics European Support Center. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3000308930
• FEI Number: 3000308930
• Name: Ortho-Clinical Diagnostics European Support Center
• Owner & Operator: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Contact Address: 1001 U.S. HWY. 202 P.O. BOX 350; Raritan NJ 08869 US
• Official Correspondent:
  • Paul Goodacre
  • 01-908-2188598-x
• US Agent:
  • Paul Goodacre
  • Ortho-Clinical Diagnostics, Inc.
  • 908 2188598
  • qertsra@orthoclinicaldiagnostics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1500 Boulevard Sebastien Brant B.P. 30335; Illkirch, CEDEX Bas-Rhin, 67411 FR
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN BK190338 | KSZ Ortho-Clinical Diagnostics European Support Center [ORTHO-CLINICAL DIAGNOSTICS, INC.]	ORTHO VISION Analyzer	2019-10-04
PMN BK160058 | KSZ Ortho-Clinical Diagnostics European Support Center [ORTHO-CLINICAL DIAGNOSTICS, INC.]	ORTHO VISION Max	2016-11-15