Source document or public record
FDA 510(k) K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test
FDA 510(k) index record K260095. Device: Heal-Check Rapid COVID-19 Antigen Self-Test. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2026-04-13.
Source
"device_name": "Heal-Check Rapid COVID-19 Antigen 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 K260095.
Device name: Heal-Check Rapid COVID-19 Antigen Self-Test. Applicant as listed: Healgen Scientific,, LLC.
Decision date: 2026-04-13. 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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