FDA 510(k) Application Details - K113435

Device Classification Name	Enzymatic, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K113435
Device Name	Enzymatic, Carbon-Dioxide
Applicant	ALFA WASSERMANN 4 Henderson Drive Caldwell, NJ 07006 US Other 510(k) Applications for this Company
Contact	HYMAN KATZ Other 510(k) Applications for this Contact
Regulation Number	862.1160   More FDA Info for this Regulation Number
Classification Product Code	KHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2011
Decision Date	07/02/2012
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