510(k) K182428 ยท NBW System, Test, Blood Glucose, Over The Counter
GlucoLeader Enhance Blood Glucose Monitoring System
| Applicant | Hmd Biomedical, Inc., Hsin Chu County, TW |
| Decision | Substantially Equivalent, May 8, 2019 |
| Received | Sep 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182428
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.