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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: 09/11/2017
Date Received: 03/23/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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: 09/11/2017
Date Received: 03/23/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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