510(k) K011465 ยท LDP Colorimetry, Acetaminophen
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 8, 2001 |
| Received | May 14, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011465
| 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.