510(k) K080887 ยท LKM Counter, Urine Particle
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
| Applicant | Sysmex America, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Mar 31, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080887
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2014 | Sysmex America, Inc. The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so Terminated |
LKM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.