510(k) K845019 ยท GKL Counter, Cell, Automated (Particle Counter)
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
| Applicant | Abbott Diagnostics, Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 26, 1985 |
| Received | Dec 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K845019
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.