510(k) K231476 · NBW System, Test, Blood Glucose, Over The Counter
TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System
| Applicant | Sinocare, Inc., Changsha, CN |
| Decision | Substantially Equivalent, Dec 1, 2023 |
| Received | May 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231476
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.