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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 the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2020-04-03 under 510(k) 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. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K192719.

When did Osom Ultra Plus Flu A&B Test Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Osom Ultra Plus Flu A&B Test Kit?

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 Osom Ultra Plus Flu A&B Test Kit?

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

K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemK182001Acucy 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.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK191514CareStart 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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