510(k) K161299 ยท NBW System, Test, Blood Glucose, Over The Counter
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Dec 23, 2016 |
| Received | May 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161299
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.