FDA 510(k) Application Details - K123320

Device Classification Name	Enzymatic Method, Ammonia   More FDA Info for this Device
510(K) Number	K123320
Device Name	Enzymatic Method, Ammonia
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 NEWARK, DE 19714-6101 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	10/26/2012
Decision Date	02/15/2013
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