FDA 510(k) Application Details - K063150

Device Classification Name	Complement C3, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K063150
Device Name	Complement C3, Antigen, Antiserum, Control
Applicant	THERMO ELECTRON OY RATASTIE 2 PO BOX 100 VANTAA FIN-01621 FI Other 510(k) Applications for this Company
Contact	PAIVI SORMUNEN Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	CZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2006
Decision Date	03/19/2007
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