510(k) K103278 ยท CGA Glucose Oxidase, Glucose
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Oct 28, 2011 |
| Received | Nov 5, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103278
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.