FDA 510(k) Application Details - K014018

Device Classification Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl   More FDA Info for this Device
510(K) Number	K014018
Device Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant	IMI 16809 BRIARDALE RD. ROCKVILLE, MD 20855 US Other 510(k) Applications for this Company
Contact	THOMAS M TSAKERIS Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	LBS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2001
Decision Date	06/24/2002
Decision	SESU - SE - WITH LIMITATIONS
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