510(k) K051459 ยท GKZ Counter, Differential Cell
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Sep 23, 2005 |
| Received | Jun 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051459
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.