FDA 510(k) Application Details - K103358

Device Classification Name	Ovarian Adnexal Mass Assessment Score Test System   More FDA Info for this Device
510(K) Number	K103358
Device Name	Ovarian Adnexal Mass Assessment Score Test System
Applicant	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355-1307 US Other 510(k) Applications for this Company
Contact	DIANA L 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	11/16/2010
Decision Date	09/01/2011
Decision	SESU - SE - WITH LIMITATIONS
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