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FDA 510(k)

Acucy® Influenza A&B Test with the Acucy® 2 System

K-Number: K241188 · 2025-04-18

ApplicantSEKISUI Diagnostics, LLC
Decision Date2025-04-18
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Acucy® Influenza A&B Test with the Acucy® 2 System is a medical device manufactured by SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2025-04-18 under approval number K241188. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acucy® Influenza A&B Test with the Acucy® 2 System?

Acucy® Influenza A&B Test with the Acucy® 2 System is a medical device that received FDA 510(k) clearance on 2025-04-18. It is manufactured by SEKISUI Diagnostics, LLC. The 510(k) number is K241188.

When was Acucy® Influenza A&B Test with the Acucy® 2 System approved by the FDA?

Acucy® Influenza A&B Test with the Acucy® 2 System received FDA 510(k) clearance on 2025-04-18, under approval number K241188.

What company makes Acucy® Influenza A&B Test with the Acucy® 2 System?

Acucy® Influenza A&B Test with the Acucy® 2 System is manufactured by SEKISUI Diagnostics, LLC.

What is the FDA product code for Acucy® Influenza A&B Test with the Acucy® 2 System?

The FDA product code for Acucy® Influenza A&B Test with the Acucy® 2 System is PSZ.

Related Clinical Trials

NCT06417853 Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) COMPLETED

Other Devices by SEKISUI Diagnostics, LLC

K182001Acucy Influenza A&B Test with the Acucy System K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test K192719Osom Ultra Plus Flu A&B Test Kit

Related Devices (Code: PSZ)

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO K153012Sofia Influenza A+B FIAQuidel Corporation K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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