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FDA 510(k)

Osom Ultra Plus Flu A&B Test Kit

K-Number: K192719 · 2020-04-03

ApplicantSEKISUI Diagnostics, LLC
Decision Date2020-04-03
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Osom Ultra Plus Flu A&B Test Kit is a medical device manufactured by SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2020-04-03 under approval number K192719. 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 Osom Ultra Plus Flu A&B Test Kit?

Osom Ultra Plus Flu A&B Test Kit is a medical device that received FDA 510(k) clearance on 2020-04-03. It is manufactured by SEKISUI Diagnostics, LLC. The 510(k) number is K192719.

When was Osom Ultra Plus Flu A&B Test Kit approved by the FDA?

Osom Ultra Plus Flu A&B Test Kit received FDA 510(k) clearance on 2020-04-03, under approval number K192719.

What company makes Osom Ultra Plus Flu A&B Test Kit?

Osom Ultra Plus Flu A&B Test Kit is manufactured by SEKISUI Diagnostics, LLC.

What is the FDA product code for Osom Ultra Plus Flu A&B Test Kit?

The FDA product code for Osom Ultra Plus Flu A&B Test Kit is PSZ.

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 K241188Acucy® Influenza A&B Test with the Acucy® 2 System

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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