510(k) K112605 ยท GKZ Counter, Differential Cell
SYSMEX XN-SERIES
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Oct 19, 2012 |
| Received | Sep 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112605
| 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 |
| Jun 10, 2016 | Sysmex Corporation The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratorie Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.