510(k) K091313 ยท GKZ Counter, Differential Cell
SYSMEX MODEL XT-4000I
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Mar 30, 2010 |
| Received | May 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091313
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.