FDA 510(k) Application Details - K083412

Device Classification Name	System, Test, C-Reactive Protein   More FDA Info for this Device
510(K) Number	K083412
Device Name	System, Test, C-Reactive Protein
Applicant	MITSUBISHI KAGAKU IATRON 701 FIFTH AVENUE FLOOR 42 SEATTLE, WA 98104 US Other 510(k) Applications for this Company
Contact	HELEN LANDICHO 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	11/18/2008
Decision Date	03/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review