FDA 510(k) Application Details - K022774

Device Classification Name	Counter, Urine Particle   More FDA Info for this Device
510(K) Number	K022774
Device Name	Counter, Urine Particle
Applicant	INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	HARVEY L KASDAN Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	LKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2002
Decision Date	10/21/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review