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I-Sens, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories3
Latest Approval2023-08-10
TypeNumberDevice NameCodeDate
510(k) K230625 ReliOn Premier BLU Blood Glucose Monitoring System NBW 2023-08-10 View
510(k) K222656 LDE4 Lancing Device QRL 2022-11-23 View
510(k) K201394 CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System NBW 2021-10-05 View
510(k) K201551 KetoSens BT Blood B-Ketone Monitoring System JIN 2020-09-09 View
510(k) K192859 CareSens S Clear BT Blood Glucose Monitoring System NBW 2020-01-24 View
510(k) K193590 CareSens S Fit BT Blood Glucose Monitoring System NBW 2020-01-17 View
510(k) K192220 ReliOn Premier Classic Blood Glucose Monitoring System NBW 2019-12-13 View
510(k) K181273 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System NBW 2018-11-01 View
510(k) K180866 CareSens S Fit Blood Glucose Monitoring System NBW 2018-08-31 View
510(k) K170463 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System JIN 2018-04-13 View
510(k) K171480 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System NBW 2017-12-13 View
510(k) K170614 CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System NBW 2017-10-19 View
510(k) K160742 NoCoding1 Plus Blood Glucose Monitoring System NBW 2016-12-16 View
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