510(k) K113547 ยท CGA Glucose Oxidase, Glucose
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Mar 28, 2012 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113547
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.