I-SENS Songdo Factory 2

FDA Device Registration & Listing · lncheon Incheon, KR · Registration 3030186688

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030186688
FEI Number
3030186688
Entity Name
I-SENS Songdo Factory 2
City/State/Country
lncheon Incheon, KR
Establishment Address
43-10, Incheon tower-daero 25beon-gil, Yeonsu-gu, lncheon Incheon 22013, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
i-SENS, Inc. (Owner Number: 9083763)
Owner / Operator Contact Address
43, Banpo-daero 28-gil, Seocho-gu, Seoul, KR-11 06646, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K151164
PMA Number
N/A

All Registered Proprietary Names

ReliOn Premier BLU Blood Glucose Monitoring System CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System CareSens S Clear BT Blood Glucose Monitoring System Tempo Blood Glucose Monitoring System KetoSens Blood ?-Ketone Monitoring System KetoSens Multi Blood ?-Ketone Monitoring System GLUCOCARD Shine Control Solution GLUCOCARD Shine XL Blood Glucose Monitoring System CareSens N Blood Glucose Monitoring System CareSens Safety Lancet CareSens N Feliz BT Blood Glucose Monitoring System CareSens N Feliz Blood Glucose Monitoring System Coag-Sense Prothrombin Time (PT) / INR Monitoring Device CareSens S Fit BT Blood Glucose Monitoring System CareSens N Voice Blood Glucose Monitoring System ReliOn Premier Voice Blood Glucose Monitoring System CareSens N Mini Blood Glucose Monitoring System ReliOn Premier COMPACT Blood Glucose Monitoring System CareSoft Lancing Device Tempo Lancing Device ReliOn Premier BLU Blood Glucose Monitoring System CareSens N POP Blood Glucose Monitoring System GLUCOCARD Shine Blood Glucose Monitoting System Fifty 50 Blood Glucose Monitoring System 2 Sport Greater Goods Essential Blood Glucose Monitoring System KetoSens BT Blood ?-Ketone Monitoring System CareSens N Voice Multi Blood Glucose Monitoring System Assure Prism multi Blood Glucose Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-10-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-01-25
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2018-04-15
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-04-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-04-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-04-08
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-10-20
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-10-14
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2019-03-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-01-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-07-18
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-07-18
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-07-18
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-07-18
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-07-18
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-07-18
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-10-20
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2022-10-20
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-08-23
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-07-18
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-07-18
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2020-09-09
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-12-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-12-02
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-12-02
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-02

Official Correspondent

Han Wool Kim

US Agent Details

Yoon Ha Cha Business: I-SENS USA, INC. Email: i-sens-usa@i-sens.com Phone: (607) 3771441

Related Public Records

Same Entity

i-SENS, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011213605 i-SENS Songdo Factory Incheon, KR
3005621222 I-SENS, INC. SEOUL, KR
3007382160 i-SENS Wonju Factory Wonju-si Gangwon, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030186688. Last updated year: 2026. Please use registration number 3030186688 when referencing this establishment in official correspondence.
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