510(k) K121654 ยท CGA Glucose Oxidase, Glucose
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Sep 5, 2012 |
| Received | Jun 5, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121654
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.