510(k) K801545 ยท GKL Counter, Cell, Automated (Particle Counter)
ORTHO AUTOMATED CELL COUNTER
| Applicant | Ortho Instruments, Walker MI, US |
| Decision | Substantially Equivalent, Sep 9, 1980 |
| Received | Jul 7, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801545
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.