Cleared Traditional

GenBody COVID-19 Ag Home Test

K251916 · Genbody.Inc. · Microbiology

Mar 2026

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K251916 is an FDA 510(k) clearance for the GenBody COVID-19 Ag Home Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Genbody.Inc. (Cheonan-Si, KR). The FDA issued a Cleared decision on March 13, 2026, 263 days after receiving the submission on June 23, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K251916 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2025
Decision Date	March 13, 2026
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QYT — Over-the-counter Covid-19 Antigen Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3984
Definition	For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.