510(k) K103842 ยท CGA Glucose Oxidase, Glucose
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 27, 2011 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2016 | Beckman Coulter Inc. UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems
The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from th Terminated |
JJE | None listed |
| Oct 24, 2012 | Beckman Coulter Inc. UniCel DxC 600/800 with
Software v5.0.11, Part Number B12218.
The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro d Terminated |
JJE | None listed |
| Oct 12, 2012 | Beckman Coulter Inc. Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853.
Product Usage: The UniCel DxC Synch Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.