FDA 510(k) Application Details - K222447

Device Classification Name	More FDA Info for this Device
510(K) Number	K222447
Device Name	FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
Applicant	Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 US Other 510(k) Applications for this Company
Contact	Catherine Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2022
Decision Date	03/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review