FDA 510(k) Application Details - DEN090004

Device Classification Name	Ovarian Adnexal Mass Assessment Score Test System   More FDA Info for this Device
510(K) Number	DEN090004
Device Name	Ovarian Adnexal Mass Assessment Score Test System
Applicant	VERMILLION 47350 FREMONT BLVD. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	GILLIAN CRUTCHER 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	07/22/2009
Decision Date	09/11/2009
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review