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510(k) K150817

Dario Blood Glucose Monitoring System by Labstyle Innovations, Ltd. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2015
Date Received
March 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Labstyle Innovations, Ltd.

  • K163159 — Dario Blood Glucose Monitoring System (July 19, 2017)

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