FDA 510(k)

QuickFinder COVID-19/流感抗原自测 / QuickFinder COVID-19/流感抗原专业测试

K号: K243262 · 2025-01-13

决定日期2025-01-13

产品代码SCA

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Osang, LLC. The 510(k) number is K243262.

When did QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test receive FDA 510(k) clearance?

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

Who is the listed applicant for QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test?

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

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.

列明Osang, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241313OHC COVID-19 抗原自测

相关器械（代码：SCA）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261212Flowflex Plus RSV + 流感A/B + COVID快速测试ACON Laboratories, Inc.K251085iHealth流感A&B/COVID-19/RSV快速检测；iHealth流感A&B/COVID-19/RSV快速检测专业版Ihealth Labs, Inc.K251092iHealth 流感A&B/COVID-19 快速测试；iHealth 流感A&B/COVID-19 快速测试专业版Ihealth Labs, Inc.K251538Status® COVID-19/流感A&BPrinceton BioMeditech Corp.K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc.K251604CareSuperb COVID-19/流感 A&B 抗原组合家用检测Access Bio, Inc.

官方来源

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