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I-Sens, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K230625ReliOn Premier BLU Blood Glucose Monitoring SystemAugust 10, 2023
K222656LDE4 Lancing DeviceNovember 23, 2022
K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SysteOctober 5, 2021
K201551KetoSens BT Blood B-Ketone Monitoring SystemSeptember 9, 2020
K192859CareSens S Clear BT Blood Glucose Monitoring SystemJanuary 24, 2020
K193590CareSens S Fit BT Blood Glucose Monitoring SystemJanuary 17, 2020
K192220ReliOn Premier Classic Blood Glucose Monitoring SystemDecember 13, 2019
K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose MonitoNovember 1, 2018
K180866CareSens S Fit Blood Glucose Monitoring SystemAugust 31, 2018
K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemApril 13, 2018
K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemDecember 13, 2017
K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SOctober 19, 2017
K160742NoCoding1 Plus Blood Glucose Monitoring SystemDecember 16, 2016
K151164Assure Prism multi Blood Glucose Monitoring SystemAugust 7, 2015
K133346SMARTLOG DIABETES MANAGEMENT SOFTWAREDecember 19, 2013
K132288CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METERNovember 22, 2013
K130696CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTAugust 21, 2013
K131419ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEMAugust 9, 2013
K121654AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTIONSeptember 5, 2012
K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMJuly 10, 2012