510(k) K012904 ยท GKZ Counter, Differential Cell
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 21, 2001 |
| Received | Aug 29, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012904
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.