510(k) K150817 ยท NBW System, Test, Blood Glucose, Over The Counter
Dario Blood Glucose Monitoring System
| Applicant | Labstyle Innovations, Ltd., Charlott NC, US |
| Decision | Substantially Equivalent, Dec 21, 2015 |
| Received | Mar 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150817
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2019 | LABSTYLE INNOVATIONS Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2 Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.