510(k) K171883 ยท LKM Counter, Urine Particle
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Apr 23, 2018 |
| Received | Jun 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171883
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.