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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 the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2025-04-18 under 510(k) 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. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K241188.

When did Acucy® Influenza A&B Test with the Acucy® 2 System receive FDA 510(k) clearance?

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

Who is the listed applicant for Acucy® Influenza A&B Test with the Acucy® 2 System?

The FDA 510(k) record lists SEKISUI Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing SEKISUI Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192719Osom Ultra Plus Flu A&B Test KitK182001Acucy Influenza A&B Test with the Acucy SystemK181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

Related Devices (Code: PSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLCK191514CareStart Flu A&B PlusAccess Bio, 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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