510(k) K172604 ยท GKZ Counter, Differential Cell
XW-100 Automated Hematology Analyzer for CLIA Waived Use
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Nov 6, 2017 |
| Received | Aug 30, 2017 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K172604
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.