FDA 510(k) Application Details - K983391

Device Classification Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)   More FDA Info for this Device
510(K) Number	K983391
Device Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant	DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. LOS ANGELES, CA 90045-5597 US Other 510(k) Applications for this Company
Contact	EDWARD M LEVINE 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	09/25/1998
Decision Date	10/15/1998
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