510(k) K141681 ยท GKZ Counter, Differential Cell
SYSMEX XN SERIES
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Dec 5, 2014 |
| Received | Jun 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141681
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2017 | Sysmex America Inc Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.