510(k) K914256 ยท GKL Counter, Cell, Automated (Particle Counter)
YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
| Applicant | Intl. Remote Imaging Systems, Chatsworth CA, US |
| Decision | Substantially Equivalent, May 1, 1992 |
| Received | Sep 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914256
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.