Data / Medical devices / South Korea / Genbody Inc.
Genbody Inc.: FDA-registered device maker in Cheonan Chungnam, South Korea, 1 510(k) clearance
Genbody Inc. is registered with the FDA (registration 3014660585) in Cheonan Chungnam, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014660585
- Address
- 3-18, 3-12, Eopseong 2-gil, Cheonan-si, Cheonan Chungnam, South Korea, 31077
- Owner or operator
- GenBody Inc. (10067610)
- Roles
- Manufacturer
- First device listed
- March 30, 2021
- Registered through
- 2026
- Brand names listed
- GenBody COVID-19 Ag Home Test, Genbody COVID-19 Ag
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | N | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Covid-19 Antigen Test | QYT | 2 | 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 |
|---|---|---|---|---|---|---|
| March 13, 2026 | K251916 | GenBody COVID-19 Ag Home Test | QYT | Substantially Equivalent | Genbody.Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Coronavirus Antigen Detection Test System.
- All makers of Over-The-Counter Covid-19 Antigen Test
Updated March 13, 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.