FDA 510(k) Applications Submitted by i-SENS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130696 |
03/14/2013 |
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
| K131419 |
05/16/2013 |
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
| K132288 |
07/23/2013 |
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER |
i-SENS, Inc. |
| K230625 |
03/06/2023 |
ReliOn Premier BLU Blood Glucose Monitoring System |
i-SENS, Inc. |
| K222656 |
09/02/2022 |
LDE4 Lancing Device |
i-SENS, Inc. |
| K133346 |
10/30/2013 |
SMARTLOG DIABETES MANAGEMENT SOFTWARE |
i-SENS, Inc. |
| K120351 |
02/06/2012 |
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA |
i-SENS, Inc. |
| K120759 |
03/13/2012 |
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION |
i-SENS, Inc. |
| K080923 |
04/02/2008 |
CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB |
i-SENS, Inc. |
| K121133 |
04/13/2012 |
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
| K121654 |
06/05/2012 |
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION |
i-SENS, Inc. |
| K083468 |
11/24/2008 |
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) |
i-SENS, Inc. |
| K100937 |
04/05/2010 |
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE |
i-SENS, Inc. |
| K103278 |
11/05/2010 |
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION |
i-SENS, Inc. |
| K201551 |
06/09/2020 |
KetoSens BT Blood B-Ketone Monitoring System |
i-SENS, Inc. |
| K170463 |
02/15/2017 |
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System |
i-SENS, Inc. |
| K170614 |
03/01/2017 |
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K160742 |
03/17/2016 |
NoCoding1 Plus Blood Glucose Monitoring System |
i-SENS, INC. |
| K180866 |
04/02/2018 |
CareSens S Fit Blood Glucose Monitoring System |
i-SENS, Inc. |
| K151164 |
05/01/2015 |
Assure Prism multi Blood Glucose Monitoring System |
i-Sens, Inc. |
| K181273 |
05/14/2018 |
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System |
i-SENS, Inc. |
| K171480 |
05/19/2017 |
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System |
i-SENS, Inc. |
| K201394 |
05/27/2020 |
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K192220 |
08/15/2019 |
ReliOn Premier Classic Blood Glucose Monitoring System |
i-SENS, Inc. |
| K192859 |
10/04/2019 |
CareSens S Clear BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K193590 |
12/23/2019 |
CareSens S Fit BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K103396 |
11/19/2010 |
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION |
i-SENS, Inc. |
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