510(k) K153201 ยท NBW System, Test, Blood Glucose, Over The Counter
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
| Applicant | Sd Biosensor, Suwon-Si, KR |
| Decision | Substantially Equivalent, Jun 24, 2016 |
| Received | Nov 4, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153201
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.