510(k) K770385 ยท GKL Counter, Cell, Automated (Particle Counter)
LATELET DETERMIN. KIT, CAT NO. 2521
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Apr 8, 1977 |
| Received | Feb 28, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770385
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.