510(k) K984014 ยท JIX Calibrator, Multi-Analyte Mixture
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 23, 1998 |
| Received | Nov 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984014
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Beckman Coulter Inc SYNCHRON Clinical Systems Enzyme Validator Kit Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.