FDA 510(k) Application Details - K955798

Device Classification Name	Igg, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K955798
Device Name	Igg, Antigen, Antiserum, Control
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN BT29 4QY IE Other 510(k) Applications for this Company
Contact	JULIE TAYLOR Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1995
Decision Date	04/05/1996
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