510(k) K120759 ยท CGA Glucose Oxidase, Glucose
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Jun 5, 2012 |
| Received | Mar 13, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120759
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.