FDA 510(k) Application Details - K143534

Device Classification Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)   More FDA Info for this Device
510(K) Number	K143534
Device Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant	ROCHE PROFESSIONAL DIAGNOSTICS 9115 HAGUE ROAD INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	LINDA MCCAMMACK 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	12/12/2014
Decision Date	08/06/2015
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