510(k) K232416 ยท LKM Counter, Urine Particle
AUTION EYE AI-4510 Urine Particle Analysis System
| Applicant | Arkray, Inc., Kyoto, JP |
| Decision | Substantially Equivalent, May 3, 2024 |
| Received | Aug 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232416
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.