510(k) K113208 ยท CGA Glucose Oxidase, Glucose
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Jan 26, 2012 |
| Received | Nov 1, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113208
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.