FDA 510(k) Application Details - K112538

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K112538
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	HYMAN KATZ 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	09/01/2011
Decision Date	03/29/2012
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