510(k) K032287 ยท JIX Calibrator, Multi-Analyte Mixture
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Aug 18, 2003 |
| Received | Jul 24, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032287
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.