FDA 510(k) Application Details - K102673

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K102673
Device Name	System, Test, Rheumatoid Factor
Applicant	PHADIA US INC. 4169 COMMERCIAL AVE. PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	MARTIN M MANN Other 510(k) Applications for this Contact
Regulation Number	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2010
Decision Date	09/30/2011
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