510(k) K110251 ยท JIX Calibrator, Multi-Analyte Mixture
SYNCHRON MULTI CALIBRATOR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, May 25, 2011 |
| Received | Jan 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2012 | Beckman Coulter Inc. Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600.
The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.