FDA 510(k) Application Details - K002674

Device Classification Name	Albumin, Fitc, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K002674
Device Name	Albumin, Fitc, 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	866.5040   More FDA Info for this Regulation Number
Classification Product Code	DDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2000
Decision Date	10/05/2000
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