FDA 510(k) Application Details - K980887

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K980887
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. PLEASANTON, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	Patricia M Klimley 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	03/09/1998
Decision Date	06/29/1998
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