FDA 510(k) Application Details - K961169

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K961169
Device Name	System, Test, Rheumatoid Factor
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN BT29 4QY IE Other 510(k) Applications for this Company
Contact	P. ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/1996
Decision Date	06/26/1996
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