510(k) K100937 ยท NBW System, Test, Blood Glucose, Over The Counter
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Dec 21, 2010 |
| Received | Apr 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100937
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.