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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 K150817
Device Name Dario Blood Glucose Monitoring System
Applicant
Labstyle Innovations, Ltd.
3521 Hatwynn Rd.
Charlott,  NC  28269
Applicant Contact TRACEY WIELINSKI
Correspondent
Labstyle Innovations, Ltd.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact TRACEY WIELINSKI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received03/27/2015
Decision Date 12/21/2015
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
Recalls CDRH Recalls
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