510(k) clearance

CVS Advanced PLUS Blood Glucose Monitoring System

FDA 510(k) source

510(k) number

K260689

Applicant

I-Sens, Inc.

Decision date

Oct 2, 2026

Date received

Mar 3, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Seoul, KR