FDA 510(k) Application Details - K131140

Device Classification Name	Automated Digital Image Manual Interpretation Microscope   More FDA Info for this Device
510(K) Number	K131140
Device Name	Automated Digital Image Manual Interpretation Microscope
Applicant	OMNYX, LLC 62 FOREST STREET, SUITE 300 MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	GAIL E RADCLIFFE Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	OEO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2013
Decision Date	04/01/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review