510(k) K102816 ยท NBW System, Test, Blood Glucose, Over The Counter
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Sep 15, 2011 |
| Received | Sep 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102816
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.