FDA 510(k) Application Details - K960054

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K960054
Device Name	Automated Urinalysis System
Applicant	INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	ALAN E KOONTZ, PH.D. Other 510(k) Applications for this Contact
Regulation Number	862.2900   More FDA Info for this Regulation Number
Classification Product Code	KQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/1996
Decision Date	03/22/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review