Data / Medical devices / Glucose Oxidase, Glucose / South Korea
FDA-registered makers of Glucose Oxidase, Glucose in South Korea: 7 establishments
7 establishments in South Korea are registered with the FDA to make Glucose Oxidase, Glucose (product code CGA). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Glucose Oxidase, Glucose
- Product code
- CGA
- Country
- South Korea
Makers of Glucose Oxidase, Glucose in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| I-SENS Songdo Factory 2 | lncheon Incheon, South Korea | Manufacturer | 1 | June 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| I-Sens, Inc. | Seoul, South Korea | Specification developer | 1 | June 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| i-SENS Songdo Factory | Incheon, South Korea | Contract manufacturer, Manufacturer | 1 | June 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| i-SENS Wonju Factory | Wonju-si Gangwon, South Korea | Contract manufacturer, Manufacturer | 1 | June 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| OSANG Healthcare CO., LTD. | ANYANG Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SD Biosensor, Inc. | Suwon-si Gyeonggi, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SD Biosensor, Inc. | Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.