510(k) K203711 ยท NBW System, Test, Blood Glucose, Over The Counter
IWL2020 Blood Glucose Monitoring System
| Applicant | Roche Diabetes Care, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 6, 2022 |
| Received | Dec 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203711
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.