FDA 510(k) Application Details - DEN060001

Device Classification Name	Calprotectin, Fecal   More FDA Info for this Device
510(K) Number	DEN060001
Device Name	Calprotectin, Fecal
Applicant	GENOVA DIAGNOSTICS 63 ZILLICOA ST. ASHEVILLE, NC 28801-1074 US Other 510(k) Applications for this Company
Contact	PATRICK HANAWAY Other 510(k) Applications for this Contact
Regulation Number	866.5180   More FDA Info for this Regulation Number
Classification Product Code	NXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2006
Decision Date	04/26/2006
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review