510(k) K071280 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 1, 2007 |
| Received | May 7, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071280
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.