FDA 510(k) Application Details - K232202

Device Classification Name	More FDA Info for this Device
510(K) Number	K232202
Device Name	Aperio GT 450 DX
Applicant	Leica Biosystems Imaging, Inc. 1360 Park Center Drive Vista, CA 92081 US Other 510(k) Applications for this Company
Contact	April Komplin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2023
Decision Date	04/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review