FDA 510(k) Application Details - K110534

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K110534
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN 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	02/25/2011
Decision Date	01/23/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review