510(k) K152599 ยท NBW System, Test, Blood Glucose, Over The Counter
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
| Applicant | Ok Biotech Co., Ltd., Hsinchu City, TW |
| Decision | Substantially Equivalent, Jul 20, 2016 |
| Received | Sep 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152599
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.