510(k) K014034 ยท JFL Ph Rate Measurement, Carbon-Dioxide
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 18, 2001 |
| Received | Dec 7, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Beckman Coulter Inc Synchron LX Clinical Systems, Operating Software, All versions. Terminated |
EXE | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Synchron LX Clinical Systems Software Terminated |
None listed | |
| Nov 6, 2003 | Beckman Coulter Inc Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems. Terminated |
JQP | None listed |
| Feb 5, 2003 | Beckman Coulter Inc SYNCHRON LX20 AND LX20 Pro Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.