510(k) K954006 ยท GKL Counter, Cell, Automated (Particle Counter)
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
| Applicant | Intl. Remote Imaging Systems, Chatsworth CA, US |
| Decision | Substantially Equivalent, Mar 12, 1996 |
| Received | Aug 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954006
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.