FDA 510(k) Application Details - K093957

Device Classification Name	Test, Epithelial Ovarian Tumor Associated Antigen (He4)   More FDA Info for this Device
510(K) Number	K093957
Device Name	Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Applicant	FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY MALVERN, PA 19355-1307 US Other 510(k) Applications for this Company
Contact	STACEY DOLAN 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	12/23/2009
Decision Date	03/18/2010
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