FDA 510(k) Application Details - K151378

Device Classification Name	Test, Epithelial Ovarian Tumor Associated Antigen (He4)   More FDA Info for this Device
510(K) Number	K151378
Device Name	Test, Epithelial Ovarian Tumor Associated Antigen (He4)
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	866.6010   More FDA Info for this Regulation Number
Classification Product Code	OIU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2015
Decision Date	11/24/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review