510(k) K884618 ยท GKL Counter, Cell, Automated (Particle Counter)
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Jan 24, 1989 |
| Received | Nov 4, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884618
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.