FDA 510(k) Application Details - K062026

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K062026
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	ATHEROTECH, INC. 15217 SPRINGDALE STREET HUNTINGTON BEACH, CA 92649 US Other 510(k) Applications for this Company
Contact	Rebecca K Pine Other 510(k) Applications for this Contact
Regulation Number	862.1175   More FDA Info for this Regulation Number
Classification Product Code	CHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2006
Decision Date	03/06/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review