510(k) K082486 ยท NBW System, Test, Blood Glucose, Over The Counter
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
| Applicant | Bayer Healthcare, LLC, Mishawaka IN, US |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | Aug 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082486
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.