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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Urinalysis System
510(k) Number K141874
Device Name URISCAN OPTIMA
Applicant
Yd Diagnostics Corp.
#821 Samil Plz., 837-26 Yeuksam-Dong
Gangnam-Gu,  KR 135-768
Applicant Contact YANG HO DONG
Correspondent
Yd Diagnostics Corp.
#821 Samil Plz., 837-26 Yeuksam-Dong
Gangnam-Gu,  KR 135-768
Correspondent Contact YANG HO DONG
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
JFY   JIR  
Date Received07/11/2014
Decision Date 05/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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