FDA 510(k) Application Details - K051456

Device Classification Name	Indirect Copper Assay, Ceruloplasmin   More FDA Info for this Device
510(K) Number	K051456
Device Name	Indirect Copper Assay, Ceruloplasmin
Applicant	SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO MILANO 20155 IT Other 510(k) Applications for this Company
Contact	DAVIDE SPADA Other 510(k) Applications for this Contact
Regulation Number	866.5210   More FDA Info for this Regulation Number
Classification Product Code	JFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2005
Decision Date	10/21/2005
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