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FreeStyle Libre 2 Flash Glucose Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193371
510(k) Type
Traditional
Applicant
Abbott Diabetes Care Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/2020
Days to Decision
190 days
Submission Type
Summary

FreeStyle Libre 2 Flash Glucose Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193371
510(k) Type
Traditional
Applicant
Abbott Diabetes Care Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/2020
Days to Decision
190 days
Submission Type
Summary