510(k) K050235 ยท GKL Counter, Cell, Automated (Particle Counter)
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
| Applicant | Iris International, Inc., Chatsworth CA, US |
| Decision | Substantially Equivalent, Mar 23, 2005 |
| Received | Feb 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050235
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.