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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K171521
Device Name DUS R-50S (Urine Chemistry system)
Applicant
DFI Co., Ltd.
388-25, Gomo-ro, Jillye-myeon, Gimhae-si
Gyeongsangnam-do,  KR 621-881
Applicant Contact Bella Cho
Correspondent
Onbix Corporation
#821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu
Seoul,  KR 06523
Correspondent Contact Ho Dong Yang
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   JFY   JIN   JIO   JIR  
JJB   JMT   JRE   KQO   LJX  
Date Received05/24/2017
Decision Date 02/16/2018
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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