FDA 510(k) Application Details - K021151

Device Classification Name	Enzymatic Method, Ammonia   More FDA Info for this Device
510(K) Number	K021151
Device Name	Enzymatic Method, Ammonia
Applicant	BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS 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	04/10/2002
Decision Date	07/13/2002
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