510(k) K100398 ยท NBW System, Test, Blood Glucose, Over The Counter
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Standard Diagnostics, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Jun 9, 2010 |
| Received | Feb 16, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100398
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.