510(k) K212248 ยท NBW System, Test, Blood Glucose, Over The Counter
GlucoLeader Enhance 2 Blood Glucose Monitoring System
| Applicant | Hmd Biomedical, Inc., Hsinchu County, TW |
| Decision | Substantially Equivalent, Aug 29, 2022 |
| Received | Jul 19, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212248
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.