510(k) K260687

VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. by Vivachek Biotech (Hangzhou) Co., Ltd. — Product Code NBW

K260687 is an FDA 510(k) premarket notification submitted by Vivachek Biotech (Hangzhou) Co., Ltd. for the device "VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.". The FDA issued a decision of Substantially Equivalent on Oct 9, 2026. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Vivachek Biotech (Hangzhou) Co., Ltd. has 10 other 510(k) clearances on record.