Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

I-Sens, Inc.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K260689 CVS Advanced PLUS Blood Glucose Monitoring SystemNBW2026-10-02 View
510(k) K230625 ReliOn Premier BLU Blood Glucose Monitoring SystemNBW2023-08-10 View
510(k) K222656 LDE4 Lancing DeviceQRL2022-11-23 View
510(k) K201394 CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemNBW2021-10-05 View
510(k) K201551 KetoSens BT Blood B-Ketone Monitoring SystemJIN2020-09-09 View
510(k) K192859 CareSens S Clear BT Blood Glucose Monitoring SystemNBW2020-01-24 View
510(k) K193590 CareSens S Fit BT Blood Glucose Monitoring SystemNBW2020-01-17 View
510(k) K192220 ReliOn Premier Classic Blood Glucose Monitoring SystemNBW2019-12-13 View
510(k) K181273 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01 View
510(k) K180866 CareSens S Fit Blood Glucose Monitoring SystemNBW2018-08-31 View
510(k) K170463 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN2018-04-13 View
510(k) K171480 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13 View
510(k) K170614 CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19 View
510(k) K160742 NoCoding1 Plus Blood Glucose Monitoring SystemNBW2016-12-16 View
510(k) K133346 SMARTLOG DIABETES MANAGEMENT SOFTWARENBW2013-12-19 View
510(k) K132288 CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METERNBW2013-11-22 View
510(k) K130696 CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEMNBW2013-08-21 View
510(k) K131419 ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEMNBW2013-08-09 View
510(k) K121654 AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTIONCGA2012-09-05 View
510(k) K121133 CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10 View
↑