FDA 510(k) Application Details - K171883

Device Classification Name	Counter, Urine Particle   More FDA Info for this Device
510(K) Number	K171883
Device Name	Counter, Urine Particle
Applicant	Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 US Other 510(k) Applications for this Company
Contact	Sharita Brooks 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	06/23/2017
Decision Date	04/23/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review