510(k) K173140 ยท NBW System, Test, Blood Glucose, Over The Counter
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glu
| Applicant | Vivachek Laboratories, Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Dec 19, 2018 |
| Received | Sep 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173140
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.