FDA 510(k) Application Details - K083080

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K083080
Device Name	System, Test, Rheumatoid Factor
Applicant	SQI DIAGNOSTICS SYSTEMS 36 METEOR DR. TORONTO, ONTARIO M9W 1A4 CA Other 510(k) Applications for this Company
Contact	Kate Smith 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	10/16/2008
Decision Date	10/29/2009
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