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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 K102188
Device Name CYBOW READER, MODELS 300 & 720
Applicant
DFI CO., LTD.
#821 SAMIL PLAZA, 837-26
YEUKSAM-DONG
GANGNAM-GU, SEOUL,  KR 135-937
Applicant Contact YANG HO-DONG
Correspondent
DFI CO., LTD.
#821 SAMIL PLAZA, 837-26
YEUKSAM-DONG
GANGNAM-GU, SEOUL,  KR 135-937
Correspondent Contact YANG HO-DONG
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIO  
JIR   JJB   JMA   JMT   JRE   LJX  
Date Received08/03/2010
Decision Date 08/09/2011
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
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