FDA 510(k) Application Details - K000469

Device Classification Name	Complement C3, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K000469
Device Name	Complement C3, Antigen, Antiserum, Control
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN BT29 4QY IE Other 510(k) Applications for this Company
Contact	R ARMSTRONG 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	02/11/2000
Decision Date	03/27/2000
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