510(k) K163159 ยท NBW System, Test, Blood Glucose, Over The Counter
Dario Blood Glucose Monitoring System
| Applicant | Labstyle Innovations, Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Jul 19, 2017 |
| Received | Nov 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163159
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.