510(k) K230625 ยท NBW System, Test, Blood Glucose, Over The Counter
ReliOn Premier BLU Blood Glucose Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Aug 10, 2023 |
| Received | Mar 6, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230625
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.