510(k) K043311 ยท NBW System, Test, Blood Glucose, Over The Counter
ASCENSIA ELITE DIABETES CARE SYSTEM
| Applicant | Bayer Healthcare, LLC, Elkhart IN, US |
| Decision | Substantially Equivalent, Dec 22, 2004 |
| Received | Dec 1, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043311
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.