FDA 510(k) Application Details - K071247

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K071247
Device Name	System, Test, Rheumatoid Factor
Applicant	DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	HELEN LEE 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	05/04/2007
Decision Date	08/08/2007
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