510(k) K260545 · NBW System, Test, Blood Glucose, Over The Counter
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System
| Applicant | Ascensia Diabetes Care, Valhalla NY, US |
| Decision | Substantially Equivalent, Aug 27, 2026 |
| Received | Feb 18, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260545
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.