FDA 510(k) Application Details - K971324

Device Classification Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides   More FDA Info for this Device
510(K) Number	K971324
Device Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant	CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	CYNTHIA SHUGART 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	04/10/1997
Decision Date	06/20/1997
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