FDA 510(k) Application Details - K991789

Device Classification Name	Ldl & Vldl Precipitation, Hdl   More FDA Info for this Device
510(K) Number	K991789
Device Name	Ldl & Vldl Precipitation, Hdl
Applicant	ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	LBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/1999
Decision Date	07/09/1999
Decision	SESE - SUBST EQUIV
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