FDA 510(k) Application Details - K063086

Device Classification Name	Transferrin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K063086
Device Name	Transferrin, 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	866.5880   More FDA Info for this Regulation Number
Classification Product Code	DDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2006
Decision Date	08/08/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review