510(k) K061150 ยท GKZ Counter, Differential Cell
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Jul 6, 2006 |
| Received | Apr 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061150
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.