Data / Medical devices / South Korea / i-SENS Songdo Factory
i-SENS Songdo Factory: FDA-registered device maker in Incheon, South Korea, 12 510(k) clearances
i-SENS Songdo Factory is registered with the FDA (registration 3011213605) in Incheon, South Korea. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011213605
- Address
- 12, Harmony-ro 275beon-gil, Yeonsu-gu, Incheon, South Korea, 22014
- Owner or operator
- i-SENS, Inc. (9083763)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- April 8, 2009
- Registered through
- 2026
- Brand names listed
- CareSens Lancet, CareSens N Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System, CareSens N Feliz Blood Glucose Monitoring System, CareSens N Mini Blood Glucose Monitoring System, CareSens N POP Blood Glucose Monitoring System, CareSens N Plus BT Blood Glucose Monitoring System, CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 10, 2023 | K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| October 5, 2021 | K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| December 13, 2019 | K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| November 1, 2018 | K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| December 13, 2017 | K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| October 19, 2017 | K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| November 22, 2013 | K132288 | CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| July 10, 2012 | K121133 | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| June 5, 2012 | K120759 | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION | CGA | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| May 3, 2012 | K120351 | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| February 10, 2009 | K083468 | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
Updated August 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.