Source document or public record
FDA 510(k) K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System
FDA 510(k) index record K241188. Device: Acucy® Influenza A&B Test with the Acucy® 2 System. Applicant as listed: SEKISUI Diagnostics, LLC. Decision date: 2025-04-18.
Source
"device_name": "Acucy® Influenza A&B Test with the Acucy® 2 System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K241188.
Device name: Acucy® Influenza A&B Test with the Acucy® 2 System. Applicant as listed: SEKISUI Diagnostics, LLC.
Decision date: 2025-04-18. Decision wording: Substantially Equivalent.
Product code: PSZ. Regulation: 21 CFR 866.3328. 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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