FDA 510(k) Application Details - K141874

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K141874
Device Name	Automated Urinalysis System
Applicant	YD DIAGNOSTICS CORP. #821 SAMIL PLAZA 837-26 YEUKSAM-DONG GANGNAM-GU, SEOUL 135-768 KR Other 510(k) Applications for this Company
Contact	YANG HO DONG 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	07/11/2014
Decision Date	05/28/2015
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