FDA 510(k) Application Details - K062316

Device Classification Name	Enzymatic Method, Ammonia   More FDA Info for this Device
510(K) Number	K062316
Device Name	Enzymatic Method, Ammonia
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.O. BOX 6101, NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	LORRAINE H PIESTRAK 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	08/09/2006
Decision Date	09/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review