GenaCheck COVID-19 Rapid Self-Test— 510(k) K251753

Name: FDA 510(k) clearance K251753
Creator: U.S. Food and Drug Administration
Published: 2025-09-05

Substantially Equivalent

Genabio Diagnostics, Inc.

FDA 510(k) clearance K251753 for GenaCheck COVID-19 Rapid Self-Test, Substantially Equivalent on 2025-09-05. Applicant: Genabio Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Genabio Diagnostics, Inc.
Product code: Code QYT
Device class: Class 2
Regulation: 21 CFR 866.3984
Advisory panel: Microbiology
Date received: 2025-06-09
Decision date: 2025-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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K251916 — GenBody COVID-19 Ag Home Test2026-03-13
K251595 — COVID-19 Detect Rapid Self -Test2025-10-12
K241313 — OHC COVID-19 Antigen Self Test2025-05-30

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