510(k) K153278 ยท NBW System, Test, Blood Glucose, Over The Counter
Wireless Smart Gluco-Monitoring System
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Aug 19, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153278
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.