FDA 510(k) Application Details - K980855

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K980855
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	DPC CIRRUS B13-B18, 111 CANFIELD AVE. RANDOLPH, NJ 07869 US Other 510(k) Applications for this Company
Contact	ROBERT M DI TULLIO 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	03/05/1998
Decision Date	04/21/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review