FDA 510(k) Application Details - K102188

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K102188
Device Name	Automated Urinalysis System
Applicant	DFI CO., LTD. #821 SAMIL PLAZA, 837-26 YEUKSAM-DONG GANGNAM-GU, SEOUL 135-937 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	08/03/2010
Decision Date	08/09/2011
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