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FDA 510(k)

Flowflex Plus COVID-19 + Flu A/B Home Test

K号: K250377 · 2025-05-10

申请人ACON Laboratories, Inc.
决定日期2025-05-10
产品代码SCA
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决定实质等同

器械摘要

Flowflex Plus COVID-19 + Flu A/B Home Test is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-05-10 under 510(k) number K250377. 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 Flowflex Plus COVID-19 + Flu A/B Home Test?

Flowflex Plus COVID-19 + Flu A/B Home Test is a medical device that received FDA 510(k) clearance on 2025-05-10. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K250377.

When did Flowflex Plus COVID-19 + Flu A/B Home Test receive FDA 510(k) clearance?

Flowflex Plus COVID-19 + Flu A/B Home Test received FDA 510(k) clearance on 2025-05-10, under 510(k) number K250377.

Who is the listed applicant for Flowflex Plus COVID-19 + Flu A/B Home Test?

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

What is the FDA product code for Flowflex Plus COVID-19 + Flu A/B Home Test?

The FDA product code for Flowflex Plus COVID-19 + Flu A/B 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ACON Laboratories, 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。

K261212Flowflex Plus RSV + 流感A/B + COVID快速测试K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripK251749Flowflex Plus RSV + Flu A/B + COVID Home TestK250085On Call® Sure GK 血糖 & 酮体监测系统；On Call® Sure Sync GK 血糖 & 酮体监测系统K232715Distinct® 数字妊娠测试K233373Flowflex® Plus COVID-19 Home Test

查看所有 16 个设备 →

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.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.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.

官方来源

在 FDA 数据库中查看 →

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