FDA 510(k) Application Details - K953971

Device Classification Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides   More FDA Info for this Device
510(K) Number	K953971
Device Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant	TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	David Johnston 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	08/23/1995
Decision Date	04/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review