510(k) K243144 ยท JOY Device, Automated Cell-Locating
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
| Applicant | Scopio Labs , Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Jun 27, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243144
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.