510(k) K850171 ยท GKL Counter, Cell, Automated (Particle Counter)
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
| Applicant | Toa Medical Electronics USA, Inc., Carson CA, US |
| Decision | Substantially Equivalent, May 13, 1985 |
| Received | Jan 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850171
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.