FDA 510(k) Application Details - K152085

Device Classification Name	Enzymatic, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K152085
Device Name	Enzymatic, Carbon-Dioxide
Applicant	RANDOX LABORATORIES LTD 55 DIAMOND ROAD ARDMORE BT29 4QY GB Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1160   More FDA Info for this Regulation Number
Classification Product Code	KHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2015
Decision Date	02/24/2016
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