FDA 510(k) clearance · back to tracker

VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.

Vivachek Biotech (Hangzhou) Co., Ltd. cleared K260687 on 2026-10-09, decision: substantially equivalent

K-number

K260687

Sponsor

Vivachek Biotech (Hangzhou) Co., Ltd.

Device

VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-09

Product code

NBW

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1345

Official FDA record

Open K260687on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.