510(k) K912494 ยท GKL Counter, Cell, Automated (Particle Counter)
SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
| Applicant | Toa Medical Electronics USA, Inc., Los Alamitos CA, US |
| Decision | Substantially Equivalent, Sep 10, 1991 |
| Received | Jun 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912494
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.