510(k) K191286 · NBW System, Test, Blood Glucose, Over The Counter
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
| Applicant | Ascensia Diabetes Care, Valhalla NY, US |
| Decision | Substantially Equivalent, Nov 8, 2019 |
| Received | May 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191286
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.