The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc 600 Synchron System Software Version 5.0 And Unicel Dxc 800 Synchron System Software Version 5.0.
| Device ID | K103842 |
| 510k Number | K103842 |
| Device Name: | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Contact | Marine Boyajian |
| Correspondent | Marine Boyajian BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-04-27 |
| Summary: | summary |