FDA 510(k) Application Details - DEN130018

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130018
Device Name	CYTOSCAN(R) DX
Applicant	Affymetrix, Inc. 3420 Central Expressway Santa Clara, CA 95051 US Other 510(k) Applications for this Company
Contact	ERIC FUNG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2013
Decision Date	01/17/2014
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review