510(k) K260687 · NBW System, Test, Blood Glucose, Over The Counter
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Oct 9, 2026 |
| Received | Mar 3, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260687
No recall in the FDA data names this 510(k).
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