510(k) K143577 ยท GKZ Counter, Differential Cell
XW-100 Automated Hematology Analyzer, XW QC CHECK
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Oct 12, 2015 |
| Received | Dec 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143577
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.