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FDA 510(k)

QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

K-Number: K243262 · 2025-01-13

ApplicantOsang, LLC
Decision Date2025-01-13
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test is a medical device manufactured by Osang, LLC. It received FDA 510(k) clearance on 2025-01-13 under approval number K243262. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test?

QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Osang, LLC. The 510(k) number is K243262.

When was QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test approved by the FDA?

QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test received FDA 510(k) clearance on 2025-01-13, under approval number K243262.

What company makes QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test?

QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test is manufactured by Osang, LLC.

What is the FDA product code for QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test?

The FDA product code for QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test is SCA.

Other Devices by Osang, LLC

K241313OHC COVID-19 Antigen Self Test

Related Devices (Code: SCA)

DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc. K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc. K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp. K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess 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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