FDA 510(k) Application Details - K122126

Device Classification Name	Calibrator, Primary   More FDA Info for this Device
510(K) Number	K122126
Device Name	Calibrator, Primary
Applicant	RANDOX LABORATORIES LIMITED 34 DIAMOND ROAD CRUMLIN ANTRIM BT29 4QY GA Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2012
Decision Date	08/14/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review