510(k) K120423 ยท NBW System, Test, Blood Glucose, Over The Counter
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
| Applicant | Bionime Corporation, Mission Viejo CA, US |
| Decision | Substantially Equivalent, Aug 3, 2012 |
| Received | Feb 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120423
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.