510(k) K103396 ยท NBW System, Test, Blood Glucose, Over The Counter
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
| Applicant | I-Sens, Inc., Garden City NY, US |
| Decision | Substantially Equivalent, Sep 27, 2011 |
| Received | Nov 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103396
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.