Libre Rio Continuous Glucose Monitoring System— 510(k) K233861

Substantially Equivalent

Abbott Diabetes Care

FDA 510(k) clearance K233861 for Libre Rio Continuous Glucose Monitoring System, Substantially Equivalent on 2024-06-07. Applicant: Abbott Diabetes Care. Device class: 2.

Clearance details

Applicant
Abbott Diabetes Care
Product code
Code SBH
Device class
Class 2
Regulation
21 CFR 862.1355
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alameda, CA, US
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