Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed) / South Korea
FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in South Korea: 12 establishments
12 establishments in South Korea are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Product code
- JJX
- Country
- South Korea
Makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| All Medicus Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boditech Med Inc. | Chuncheon Gangwon, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-SENS Songdo Factory 2 | lncheon Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Sens, Inc. | Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanoentek Inc | Hwaseong Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanoentek Inc | Seoul, South Korea | Specification developer | 0 | 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 | |
| SG BioScience, INC | Dongdaemun-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| i-SENS Songdo Factory | Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| i-SENS Wonju Factory | Wonju-si Gangwon, 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.