FDA 510(k) Application Details - K003400

Device Classification Name	System, Test, C-Reactive Protein   More FDA Info for this Device
510(K) Number	K003400
Device Name	System, Test, C-Reactive Protein
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	KAY A TAYLOR Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2000
Decision Date	05/10/2001
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