510(k) K831368 ยท GKL Counter, Cell, Automated (Particle Counter)
CELL-DYN 400 HEMOTOLOGY ANALYZER
| Applicant | Abbott Diagnostics, Mountain View CA, US |
| Decision | Substantially Equivalent, Jul 18, 1983 |
| Received | Apr 26, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831368
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.