FDA 510(k) Application Details - K062092

Device Classification Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl   More FDA Info for this Device
510(K) Number	K062092
Device Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant	PREMD, INC. 16809 BRIARDALE ROAD 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	07/24/2006
Decision Date	09/15/2006
Decision	SESU - SE - WITH LIMITATIONS
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