510(k) K113636 ยท CGA Glucose Oxidase, Glucose
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
| Applicant | Philosys Co., Ltd., New York NY, US |
| Decision | Substantially Equivalent, Mar 8, 2013 |
| Received | Dec 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113636
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.