510(k) K161834 ยท NBW System, Test, Blood Glucose, Over The Counter
One Drop Blood Glucose Monitoring System
| Applicant | Agamatrix, Inc., Salem NH, US |
| Decision | Substantially Equivalent, Nov 30, 2016 |
| Received | Jul 5, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161834
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.