510(k) K051199 ยท GKZ Counter, Differential Cell
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Aug 8, 2005 |
| Received | May 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051199
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.