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FDA 510(k)

CareSuperb COVID-19/流感 A&B 抗原组合家用检测

K号: K251604 · 2025-08-22

申请人Access Bio, Inc.
决定日期2025-08-22
产品代码SCA
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决定实质等同

器械摘要

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Access Bio, Inc.. It received FDA 510(k) clearance on 2025-08-22 under 510(k) number K251604. 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 CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is Access Bio, Inc.. The 510(k) number is K251604.

When did CareSuperb COVID-19/Flu A&B Antigen Combo Home Test receive FDA 510(k) clearance?

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test received FDA 510(k) clearance on 2025-08-22, under 510(k) number K251604.

Who is the listed applicant for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

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

What is the FDA product code for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

The FDA product code for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is SCA.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Access Bio, Inc.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。

K241915CareSuperb™ COVID-19 抗原家用检测K191514CareStart 流感 A&B Plus

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.K251563WELLlife 流感A&B家用检测仪；WELLlife 流感A&B检测仪Wondfo USA Co, Ltd.

官方来源

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