510(k) K920719 ยท GKL Counter, Cell, Automated (Particle Counter)
IVOS ANALYZER
| Applicant | Hamilton Thorne Research, Beverly MA, US |
| Decision | Substantially Equivalent, Jun 29, 1992 |
| Received | Feb 18, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920719
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.