510(k) K951189 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 13, 1995 |
| Received | Mar 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2003 | Beckman Coulter Inc Synchron CX4, CX5 and CX9 Pro Systems. Terminated |
JQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.