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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K170463
Device Name KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
Applicant
I-Sens, Inc.
43, Banpo-Daero 28-Gil
Seocho-Gu
Seoul,  KR 06646
Applicant Contact Joon Ho Jung
Correspondent
I-Sens, Inc.
43, Banpo-Daero 28-Gil
Seocho-Gu
Seoul,  KR 06646
Correspondent Contact Joon Ho Jung
Regulation Number862.1435
Classification Product Code
JIN  
Date Received02/15/2017
Decision Date 04/13/2018
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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