510(k) K850386 ยท GKL Counter, Cell, Automated (Particle Counter)
SYSTEM 8000 CELL COUNTER
| Applicant | Baker Instructions Corp., Allentown PA, US |
| Decision | Substantially Equivalent, May 2, 1985 |
| Received | Feb 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850386
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.