510(k) K182062 ยท JOY Device, Automated Cell-Locating
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Oct 30, 2018 |
| Received | Aug 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182062
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.