FDA 510(k) Application Details - K130337

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K130337
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN, ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2013
Decision Date	06/19/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review