510(k) K781628 ยท GKL Counter, Cell, Automated (Particle Counter)
HEMO-W SYSTEM
| Applicant | Coulter Electronics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 27, 1978 |
| Received | Sep 25, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781628
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.