Source document or public record
FDA 510(k) K251753 — GenaCheck COVID-19 Rapid Self-Test
FDA 510(k) index record K251753. Device: GenaCheck COVID-19 Rapid Self-Test. Applicant as listed: Genabio Diagnostics, Inc.. Decision date: 2025-09-05.
Source
"device_name": "GenaCheck COVID-19 Rapid Self-Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K251753.
Device name: GenaCheck COVID-19 Rapid Self-Test. Applicant as listed: Genabio Diagnostics, Inc..
Decision date: 2025-09-05. Decision wording: Substantially Equivalent.
Product code: QYT. Regulation: 21 CFR 866.3984. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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