510(k) K020208 ยท NBW System, Test, Blood Glucose, Over The Counter
GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
| Applicant | Bayer Group Diagnostics, Elkhart IN, US |
| Decision | Substantially Equivalent, Apr 29, 2002 |
| Received | Jan 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020208
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.