510(k) K160179 ยท NBW System, Test, Blood Glucose, Over The Counter
VivaChek Ino Blood Glucose Monitoring System
| Applicant | Vivachek Laboratories, Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Apr 21, 2017 |
| Received | Jan 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160179
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.