Medical Device Manufacturer · KR , Seoul

I-Sens, Inc.

27 submissions · 27 cleared · Since 2008
27
Total
27
Cleared
0
Denied

I-Sens, Inc. — FDA 510(k) Submissions

I-Sens, Inc. has submitted 27 FDA 510(k) premarket notifications since 2008, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Blood Glucose, Over The Counter, Glucose Oxidase, Glucose, Nitroprusside, Ketones (urinary, Non-quant.), Multiple Use Blood Lancet For Single Patient Use Only . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · NBW System, Test, Blood... · Chemistry
Aug 2023 157d
LDE4 Lancing Device
K222656 · QRL Multiple Use Blood Lancet... · General & Plastic Surgery
Nov 2022 82d
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
K201394 · NBW System, Test, Blood... · Chemistry
Oct 2021 496d
KetoSens BT Blood B-Ketone Monitoring System
K201551 · JIN Nitroprusside, Ketones... · Chemistry
Sep 2020 92d
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · NBW System, Test, Blood... · Chemistry
Jan 2020 112d
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · NBW System, Test, Blood... · Chemistry
Jan 2020 25d
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · NBW System, Test, Blood... · Chemistry
Dec 2019 120d
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
K181273 · NBW System, Test, Blood... · Chemistry
Nov 2018 171d
CareSens S Fit Blood Glucose Monitoring System
K180866 · NBW System, Test, Blood... · Chemistry
Aug 2018 151d
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
K170463 · JIN Nitroprusside, Ketones... · Chemistry
Apr 2018 422d
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
K171480 · NBW System, Test, Blood... · Chemistry
Dec 2017 208d
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
K170614 · NBW System, Test, Blood... · Chemistry
Oct 2017 232d
NoCoding1 Plus Blood Glucose Monitoring System
K160742 · NBW System, Test, Blood... · Chemistry
Dec 2016 274d
Assure Prism multi Blood Glucose Monitoring System
K151164 · NBW System, Test, Blood... · Chemistry
Aug 2015 98d
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · NBW System, Test, Blood... · Chemistry
Dec 2013 50d
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
K132288 · NBW System, Test, Blood... · Chemistry
Nov 2013 122d
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
K130696 · NBW System, Test, Blood... · Chemistry
Aug 2013 160d
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
K131419 · NBW System, Test, Blood... · Chemistry
Aug 2013 85d
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
K121654 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 2012 92d
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
K121133 · NBW System, Test, Blood... · Chemistry
Jul 2012 88d
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
K120759 · CGA Glucose Oxidase, Glucose · Chemistry
Jun 2012 84d
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
K120351 · NBW System, Test, Blood... · Chemistry
May 2012 87d
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
K103278 · CGA Glucose Oxidase, Glucose · Chemistry
Oct 2011 357d
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
K103396 · NBW System, Test, Blood... · Chemistry
Sep 2011 312d
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
K100937 · NBW System, Test, Blood... · Chemistry
Dec 2010 260d
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