510(k) K803218 ยท GKL Counter, Cell, Automated (Particle Counter)
CELL DYN 800 HEMATOLOGY ANALYZER
| Applicant | Abbott Diagnostics, Mountain View CA, US |
| Decision | Substantially Equivalent, Jun 9, 1981 |
| Received | Dec 18, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803218
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.