FDA 510(k) Application Details - K991707

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K991707
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	BECKMAN 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US Other 510(k) Applications for this Company
Contact	ANGELA BYLAND 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	05/19/1999
Decision Date	06/01/1999
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