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

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.

Clearance details

Applicant: Genbody.Inc.
Product code: 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 ↗

Recent devices under product code QYT

K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test2026-06-05
K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test2026-04-13
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.