Last synced on 14 November 2025 at 11:06 pm

FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System

Page Type
Cleared 510(K)
510(k) Number
K222447
510(k) Type
Traditional
Applicant
Abbott Diabetes Care, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/2023
Days to Decision
200 days
Submission Type
Summary

FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System

Page Type
Cleared 510(K)
510(k) Number
K222447
510(k) Type
Traditional
Applicant
Abbott Diabetes Care, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/2023
Days to Decision
200 days
Submission Type
Summary