510(k) K911626 ยท GKZ Counter, Differential Cell
SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER
| Applicant | Serono Baker Diagnostics System, Allentown PA, US |
| Decision | Substantially Equivalent, Sep 13, 1991 |
| Received | Apr 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911626
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.