Source document or public record
FDA 510(k) K232377 — Healgen Rapid COVID-19 Antigen Test
FDA 510(k) index record K232377. Device: Healgen Rapid COVID-19 Antigen Test. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2024-04-19.
Source
"device_name": "Healgen Rapid COVID-19 Antigen 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
professional use
FDA 510(k) public index record K232377.
Device name: Healgen Rapid COVID-19 Antigen Test. Applicant as listed: Healgen Scientific,, LLC.
Decision date: 2024-04-19. Decision wording: Substantially Equivalent.
Product code: QVF. Regulation: 21 CFR 866.3982. 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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