FDA 510(k) Application Details - K190332

Device Classification Name	More FDA Info for this Device
510(K) Number	K190332
Device Name	Aperio AT2 DX System
Applicant	Leica Biosystems Imaging, Inc. 1360 Park Center Dr. Vista, CA 92081 US Other 510(k) Applications for this Company
Contact	Christine Kishi 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	02/14/2019
Decision Date	05/20/2019
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