510(k) K150299 ยท NBW System, Test, Blood Glucose, Over The Counter
Gmate SMART Blood Glucose Monitoring System
| Applicant | Philosys, Inc., New York NY, US |
| Decision | Substantially Equivalent, Nov 19, 2015 |
| Received | Feb 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150299
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.