FDA 510(k) Application Details - K161691

Device Classification Name	System, Test, Low Density, Lipoprotein   More FDA Info for this Device
510(K) Number	K161691
Device Name	System, Test, Low Density, Lipoprotein
Applicant	RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN CRUMLIN BT29 4QY GB Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	MRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2016
Decision Date	03/20/2017
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