Source document or public record
FDA 510(k) K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
FDA 510(k) index record K251749. Device: Flowflex Plus RSV + Flu A/B + COVID Home Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2025-10-22.
Source
"device_name": "Flowflex Plus RSV + Flu A/B + COVID Home 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 K251749.
Device name: Flowflex Plus RSV + Flu A/B + COVID Home Test. Applicant as listed: ACON Laboratories, Inc..
Decision date: 2025-10-22. Decision wording: Substantially Equivalent.
Product code: SCA. Regulation: 21 CFR 866.3987. 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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