FDA 510(k) Application Details - K083602

Device Classification Name	Kappa, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K083602
Device Name	Kappa, Antigen, Antiserum, Control
Applicant	SENTINEL CH. SpA Via Robert Koch, 2 Milano 20152 IT Other 510(k) Applications for this Company
Contact	YANGTSE PORTELLES Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2008
Decision Date	09/03/2009
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