510(k) K040073 ยท GKZ Counter, Differential Cell
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Mar 18, 2004 |
| Received | Jan 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040073
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.