510(k) K153561 ยท NBW System, Test, Blood Glucose, Over The Counter
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Feb 16, 2017 |
| Received | Dec 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153561
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.