510(k) K112638 ยท NBW System, Test, Blood Glucose, Over The Counter
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Mar 9, 2012 |
| Received | Sep 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112638
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.