FDA 510(k) Application Details - K001009

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K001009
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, 55 DIAMOND ROAD CRUMLIN, CO. ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	P. ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2000
Decision Date	08/04/2000
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