FDA 510(k) Application Details - K033921

Device Classification Name	Enzymatic Method, Ammonia   More FDA Info for this Device
510(K) Number	K033921
Device Name	Enzymatic Method, Ammonia
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN C1E 2A6 CA Other 510(k) Applications for this Company
Contact	NANCY OLSCAMP 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	12/18/2003
Decision Date	03/10/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review