FDA 510(k) Application Details - K152344

Device Classification Name	Enzymatic Method, Bilirubin   More FDA Info for this Device
510(K) Number	K152344
Device Name	Enzymatic Method, Bilirubin
Applicant	RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD,ARDMORE CRUMLIN, COUNTY ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	JFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2015
Decision Date	01/28/2016
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