510(k) K101204 ยท CGA Glucose Oxidase, Glucose
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Aug 31, 2011 |
| Received | Apr 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101204
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.