510(k) K091539 ยท GKL Counter, Cell, Automated (Particle Counter)
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
| Applicant | Iris Diagnostics, Chatsworth CA, US |
| Decision | Substantially Equivalent, Aug 31, 2010 |
| Received | May 26, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091539
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.