FDA 510(k) Application Details - K063766

Device Classification Name	Transferrin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K063766
Device Name	Transferrin, Antigen, Antiserum, Control
Applicant	GOOD BIOTECH CORP. 38, 34TH RD. TAICHUNG INDUSTRIAL PARK TAICHUNG 407 TW Other 510(k) Applications for this Company
Contact	VICTOR CHIOU 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	12/20/2006
Decision Date	04/23/2007
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