510(k) K070910 ยท LKM Counter, Urine Particle
SYSMEX MODEL UF1000I
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, May 25, 2007 |
| Received | Apr 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070910
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.