Source document or public record
FDA 510(k) K253318 — Clungene RSV Antigen Rapid Test
FDA 510(k) index record K253318. Device: Clungene RSV Antigen Rapid Test. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd.. Decision date: 2026-01-30.
Source
"device_name": "Clungene RSV Antigen Rapid 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 K253318.
Device name: Clungene RSV Antigen Rapid Test. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd..
Decision date: 2026-01-30. Decision wording: Substantially Equivalent.
Product code: GQG. Regulation: 21 CFR 866.3480. 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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