FDA 510(k), K172723, Dario LC Blood Glucose Monitoring System

FDA 510(k), K172723, Dario LC Blood Glucose Monitoring System

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510(K) Number: K172723
Device Name: Dario LC Blood Glucose Monitoring System
Manufacturer: Erez Raphael
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: KXA
Date Received: 09/11/2017
Decision Date: 03/23/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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