510(k) K120351 ยท NBW System, Test, Blood Glucose, Over The Counter
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, May 3, 2012 |
| Received | Feb 6, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120351
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.