510(k) K180020 ยท GKZ Counter, Differential Cell
HemoScreen Hematology Analyzer
| Applicant | Pixcell Medical Technologies, Ltd., Pob 113 Yoknaem Ilit, IL |
| Decision | Substantially Equivalent, Oct 29, 2018 |
| Received | Jan 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180020
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.