510(k) K210346 ยท GKZ Counter, Differential Cell
Sysmex XW-100 Automated Hematology Analyzer
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Nov 8, 2022 |
| Received | Feb 8, 2021 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K210346
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.