FDA 510(k) Application Details - K080561

Device Classification Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)   More FDA Info for this Device
510(K) Number	K080561
Device Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US Other 510(k) Applications for this Company
Contact	SANDRA L PERREAND Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	LTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2008
Decision Date	04/10/2009
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