510(k) K771353 ยท GKL Counter, Cell, Automated (Particle Counter)
PLATELET COUNTER & HEMATOCRIT ACCES.
| Applicant | Hycel, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 10, 1977 |
| Received | Jul 22, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771353
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.