K251916

Substantially Equivalent

GenBody COVID-19 Ag Home Test

Applicant: Genbody.Inc.
Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.