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

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..

Clearance details

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

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