FDA 510(k) Application Details - K051962

Device Classification Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl   More FDA Info for this Device
510(K) Number	K051962
Device Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant	ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	LINDA MORRIS 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	07/19/2005
Decision Date	08/25/2005
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