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510(k) K192859

CareSens S Clear BT Blood Glucose Monitoring System by I-Sens, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2020
Date Received
October 4, 2019
Clearance Type
Special
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

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  • K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitor (April 13, 2018)
  • K171480 — NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitorin (December 13, 2017)

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