510(k) K253212 ยท GKZ Counter, Differential Cell
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, May 27, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253212
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.