510(k) K051693 ยท GKL Counter, Cell, Automated (Particle Counter)
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 7, 2005 |
| Received | Jun 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051693
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.