510(k) K133045 ยท NBW System, Test, Blood Glucose, Over The Counter
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Infopia Co, Ltd., Anyang, Kyunggi, KR |
| Decision | Substantially Equivalent, Apr 10, 2014 |
| Received | Sep 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133045
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.