FDA 510(k) Application Details - K002585

Device Classification Name	Transferrin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K002585
Device Name	Transferrin, Antigen, Antiserum, Control
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 4QY IE Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG 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	08/21/2000
Decision Date	02/05/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review