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..

Clearance details

Applicant: Genbody.Inc.
Product code: Code QYT
Advisory panel: Microbiology
Date received: 2025-06-23
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheonan-Si, KR

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