510(k) K081610 ยท GKZ Counter, Differential Cell
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Aug 29, 2008 |
| Received | Jun 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081610
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.