Data / Medical devices / Nitroprusside, Ketones (Urinary, Non-Quant.) / South Korea
FDA-registered makers of Nitroprusside, Ketones (Urinary, Non-Quant.) in South Korea: 6 establishments
6 establishments in South Korea are registered with the FDA to make Nitroprusside, Ketones (Urinary, Non-Quant.) (product code JIN). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Nitroprusside, Ketones (Urinary, Non-Quant.)
- Product code
- JIN
- Country
- South Korea
Makers of Nitroprusside, Ketones (Urinary, Non-Quant.) 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 | 2 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| I-Sens, Inc. | Seoul, South Korea | Specification developer | 2 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| i-SENS Wonju Factory | Wonju-si Gangwon, South Korea | Manufacturer | 2 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Chungdo Pharm. Co., Ltd. | Chuncheon-si Gangwon, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dfi Co., Ltd. | Gimhae Jeonnam, South Korea | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Yd Diagnostics | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.