510(k) K233861

Device

Libre Rio Continuous Glucose Monitoring System

Applicant

Abbott Diabetes Care

510(k) number

K233861

Product code

SBH

Decision

Substantially Equivalent (SESE)

Decision date

2024-06-07

Date received

2023-12-06

Regulation

862.1355

Classification name

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Medical specialty

Clinical Chemistry

Review panel

Clinical Chemistry

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N