510(k) K052163 ยท CFR Hexokinase, Glucose
ADVIA IMS GLUCOSE ASSAY
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 11, 2005 |
| Received | Aug 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052163
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.