510(k) clearance
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.
- 510(k) number
- K260687
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Decision date
- Oct 9, 2026
- Date received
- Mar 3, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NBW
- Device type
- System, Test, Blood Glucose, Over The Counter
- Device class
- Class II
- Regulation
- 21 CFR 862.1345
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Hangzhou, CN