510(k) K142689 ยท CGA Glucose Oxidase, Glucose
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Aug 6, 2015 |
| Received | Sep 22, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142689
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.