FDA 510(k) Application Details - K182062

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K182062
Device Name	Device, Automated Cell-Locating
Applicant	Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 US Other 510(k) Applications for this Company
Contact	Jessica Rivera-Montejo Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	JOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2018
Decision Date	10/30/2018
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