510(k) K001683 ยท GKL Counter, Cell, Automated (Particle Counter)
SYSMEX R-500
| Applicant | Sysmex Corporation of America, Long Grove IL, US |
| Decision | Substantially Equivalent, Aug 21, 2000 |
| Received | Jun 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001683
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.