FDA 510(k) Application Details - K072939

Device Classification Name	Test, Epithelial Ovarian Tumor Associated Antigen (He4)   More FDA Info for this Device
510(K) Number	K072939
Device Name	Test, Epithelial Ovarian Tumor Associated Antigen (He4)
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	866.6010   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	10/17/2007
Decision Date	06/09/2008
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