FDA 510(k) Application Details - K073277

Device Classification Name	System, Test, C-Reactive Protein   More FDA Info for this Device
510(K) Number	K073277
Device Name	System, Test, C-Reactive Protein
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	KERWIN L KAUFMAN 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	11/21/2007
Decision Date	03/06/2008
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