FDA 510(k) Application Details - K160090

Device Classification Name	Ovarian Adnexal Mass Assessment Score Test System   More FDA Info for this Device
510(K) Number	K160090
Device Name	Ovarian Adnexal Mass Assessment Score Test System
Applicant	Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Diana Dickson 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	01/15/2016
Decision Date	05/16/2016
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