510(k) K133790 ยท NBW System, Test, Blood Glucose, Over The Counter
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, May 22, 2014 |
| Received | Dec 9, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133790
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.