510(k) K964375 ยท GKL Counter, Cell, Automated (Particle Counter)
SYSMEX SE/RAM-1
| Applicant | Sysmex Corp., Long Grove IL, US |
| Decision | Substantially Equivalent, Mar 13, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964375
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.