FDA 510(k) Application Details - K991371

Device Classification Name	Photometric Method, Ammonia   More FDA Info for this Device
510(K) Number	K991371
Device Name	Photometric Method, Ammonia
Applicant	CARESIDE, INC. 6100 BRISTOL PKWY. CULVER CITY, CA 90230 US Other 510(k) Applications for this Company
Contact	KENNETH B ASSARCH, PHARM Other 510(k) Applications for this Contact
Regulation Number	862.1065   More FDA Info for this Regulation Number
Classification Product Code	JID Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/1999
Decision Date	08/03/1999
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