510(k) K193407 · NBW System, Test, Blood Glucose, Over The Counter
Contour® next GEN Blood Glucose Monitoring System
| Applicant | Ascensia Diabetes Care, Valhalla NY, US |
| Decision | Substantially Equivalent, Dec 23, 2021 |
| Received | Dec 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2023 | Ascensia Diabetes Care US, Inc. Contour next GEN Blood Glucose Monitoring System Open, Classified |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.