FDA 510(k) Application Details - K000661

Device Classification Name	Prealbumin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K000661
Device Name	Prealbumin, Antigen, Antiserum, Control
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 4QY IE Other 510(k) Applications for this Company
Contact	P ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	866.5060   More FDA Info for this Regulation Number
Classification Product Code	JZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2000
Decision Date	04/13/2000
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