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FDA 510(k)

iHealth 流感A&B/COVID-19 快速测试；iHealth 流感A&B/COVID-19 快速测试专业版

K号: K251092 · 2025-12-12

申请人Ihealth Labs, Inc.
决定日期2025-12-12
产品代码SCA
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器械摘要

iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro is the device name listed in this FDA 510(k) record. The listed applicant is Ihealth Labs, Inc.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K251092. 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 iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro?

iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Ihealth Labs, Inc.. The 510(k) number is K251092.

When did iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro receive FDA 510(k) clearance?

iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro received FDA 510(k) clearance on 2025-12-12, under 510(k) number K251092.

Who is the listed applicant for iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro?

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

What is the FDA product code for iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro?

The FDA product code for iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro 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Ihealth Labs, 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。

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K243146iCare 应用程序K233842iHealth COVID-19 抗原快速检测

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.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.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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