FDA 510(k) Application Details - K034000

Device Classification Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides   More FDA Info for this Device
510(K) Number	K034000
Device Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant	CLINICAL DATA, INC. 1075 WEST LAMBERT ROAD BREA, CA 92821-2944 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING 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	12/24/2003
Decision Date	03/10/2004
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	Y
Expedited Review