510(k) K954607 ยท GKL Counter, Cell, Automated (Particle Counter)
RETICULOCYTE METHOD
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 30, 1996 |
| Received | Oct 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954607
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.