510(k) K083002 ยท LKM Counter, Urine Particle
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Feb 3, 2009 |
| Received | Oct 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083002
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.