GenBody COVID-19 Ag Home Test— 510(k) K251916

Name: FDA 510(k) clearance K251916
Creator: U.S. Food and Drug Administration
Published: 2026-03-13

Substantially Equivalent

Genbody.Inc.

FDA 510(k) clearance K251916 for GenBody COVID-19 Ag Home Test, Substantially Equivalent on 2026-03-13. Applicant: Genbody.Inc.. Device class: 2.

Summary

Genbody's GenBody COVID-19 Ag Home Test is filed under QYT, over-the-counter COVID-19 antigen tests. The record doesn't describe the test beyond its name and that code name.

Class II, 21 CFR 866.3984. Microbiology is both the classification panel and the review panel. It was a Traditional 510(k).

Genbody filed from Cheonan-Si, South Korea. The decision came 263 calendar days after receipt (June 23, 2025 to March 13, 2026).

Clearance details

Applicant: Genbody.Inc.
Product code: Product code QYT
Device class: Class 2
Regulation: 21 CFR 866.3984
Advisory panel: Microbiology
Date received: 2025-06-23
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheonan-Si, KR

Download summary PDF View on FDA.gov ↗

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K251595 — COVID-19 Detect Rapid Self -Test2025-10-12
K251753 — GenaCheck COVID-19 Rapid Self-Test2025-09-05
K241313 — OHC COVID-19 Antigen Self Test2025-05-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.