FDA 510(k) Application Details - K043546

Device Classification Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides   More FDA Info for this Device
510(K) Number	K043546
Device Name	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant	DADE BEHRING, INC. 500 GBC DR., M/S 514 P.O. BOX 6101 NEWARK, DE 19714 US Other 510(k) Applications for this Company
Contact	STANLEY GORAK 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	12/23/2004
Decision Date	01/18/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review