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Abbott Diabetes Care, Inc. FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System510(k)Apr 23, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 23, 2024
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System510(k)Apr 13, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 13, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System510(k)Mar 3, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Mar 3, 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System510(k)Feb 21, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 21, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System510(k)May 26, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System510(k)May 26, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 26, 2022
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)510(k)Nov 22, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Nov 22, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System510(k)Aug 11, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)510(k)Jul 30, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 30, 2021

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