FDA 510(k) Application Details - K023891

Device Classification Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)   More FDA Info for this Device
510(K) Number	K023891
Device Name	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Applicant	TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	LOIS NAKAYAMA 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	11/22/2002
Decision Date	12/06/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review