510(k) K222126 · NBW System, Test, Blood Glucose, Over The Counter
VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 16, 2024 |
| Received | Jul 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222126
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.