510(k) K113670 ยท CGA Glucose Oxidase, Glucose
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Infopia Co, Ltd., Fullerton CA, US |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Dec 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113670
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.