510(k) K103544 ยท NBW System, Test, Blood Glucose, Over The Counter
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
| Applicant | Agamatrix, Inc., Salem NH, US |
| Decision | Substantially Equivalent, Dec 7, 2011 |
| Received | Dec 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103544
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.