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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 K181024
Device Name DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
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 Plz., 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   CEN   JIN   JIO   JIR  
JJB   JMT   JRE   LJX  
Date Received04/18/2018
Decision Date 05/23/2018
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
Predetermined Change
Control Plan Authorized		 No
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