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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K163159
Device Name Dario Blood Glucose Monitoring System
LabStyle Innovations, Ltd.
9 Halamish Street, North Industrial Park
caesarea,  IL 3890000
Applicant Contact erez raphael
Qualtra Consulting, Inc.
5 Casie Lane
pepperell,  MA  01463
Correspondent Contact tracey wielinski
Regulation Number862.1345
Classification Product Code
Date Received11/10/2016
Decision Date 07/19/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02910674
Reviewed by Third Party No
Combination Product No