510(k) K850354 ยท GKZ Counter, Differential Cell
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS
| Applicant | Toa Medical Electronics USA, Inc., Carson CA, US |
| Decision | Substantially Equivalent, May 20, 1985 |
| Received | Jan 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850354
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.