FDA 510(k) Application Details - K964185

Device Classification Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)   More FDA Info for this Device
510(K) Number	K964185
Device Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant	ABBOTT DIAGNOSTICS 200 ABBOTT PARK RD. DEPT. 49C AP31 ABBOTT PARK, IL 60064-3537 US Other 510(k) Applications for this Company
Contact	JOY C SONSALLA 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	10/21/1996
Decision Date	11/04/1997
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