FDA 510(k) Application Details - K150819

Device Classification Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides   More FDA Info for this Device
510(K) Number	K150819
Device Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant	Randox Laboratories Limited 55 Diamond Road Crumlin BT29 4Qy GB Other 510(k) Applications for this Company
Contact	Pauline Armstrong Other 510(k) Applications for this Contact
Regulation Number	862.1705   More FDA Info for this Regulation Number
Classification Product Code	CDT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2015
Decision Date	08/06/2015
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