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FDA 510(k)

Acucy Influenza A&B Test with the Acucy System

K-Number: K182001 · 2018-12-17

ApplicantSEKISUI Diagnostics, LLC
Decision Date2018-12-17
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Acucy Influenza A&B Test with the Acucy System is a medical device manufactured by SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2018-12-17 under approval number K182001. 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 System?

Acucy Influenza A&B Test with the Acucy System is a medical device that received FDA 510(k) clearance on 2018-12-17. It is manufactured by SEKISUI Diagnostics, LLC. The 510(k) number is K182001.

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

Acucy Influenza A&B Test with the Acucy System received FDA 510(k) clearance on 2018-12-17, under approval number K182001.

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

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

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

The FDA product code for Acucy Influenza A&B Test with the Acucy 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

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test K192719Osom Ultra Plus Flu A&B Test Kit K241188Acucy® Influenza A&B Test with the Acucy® 2 System

Related Devices (Code: PSZ)

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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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