FDA 510(k) Application Details - K990774

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K990774
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	ABBOTT LABORATORIES 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	KAREN L GATES Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	DHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/1999
Decision Date	05/11/1999
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