FDA 510(k) Application Details - K153607

Device Classification Name	Ovarian Adnexal Mass Assessment Score Test System   More FDA Info for this Device
510(K) Number	K153607
Device Name	Ovarian Adnexal Mass Assessment Score Test System
Applicant	ROCHE DIAGNOSTICS 9115 HAGUE ROAD INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	Angelo Pereira Other 510(k) Applications for this Contact
Regulation Number	866.6050   More FDA Info for this Regulation Number
Classification Product Code	ONX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2015
Decision Date	06/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review