FDA 510(k) Application Details - K123677

Device Classification Name	Enzymatic Method, Ammonia   More FDA Info for this Device
510(K) Number	K123677
Device Name	Enzymatic Method, Ammonia
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 NEWARK, DE 19702 US Other 510(k) Applications for this Company
Contact	ROSE T MARINELLI Other 510(k) Applications for this Contact
Regulation Number	862.1065   More FDA Info for this Regulation Number
Classification Product Code	JIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2012
Decision Date	03/07/2013
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