510(k) K250943 ยท GKZ Counter, Differential Cell
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Jun 25, 2025 |
| Received | Mar 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250943
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.