FDA 510(k)

Fastep COVID-19 抗原笔家用检测；Fastep COVID-19 抗原笔检测

K号: K260754 · 2026-06-05

决定日期2026-06-05

产品代码QYT

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决定实质等同

器械摘要

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K260754. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test?

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Assure Tech., LLC. The 510(k) number is K260754.

When did Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test receive FDA 510(k) clearance?

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260754.

Who is the listed applicant for Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test?

FDA 510(k)记录显示，Assure Tech., LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test?

The FDA product code for Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test is QYT.

列明Assure Tech., 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。

K261984AssureTech 快速杯测试；AssureTech 多药物尿液测试杯 K252259AssureTech 快速杯测试；AssureTech 多药物尿液测试杯 K250117FaStep 妊娠快速测试卡式；Fastep HCG 快速测试卡式 K243996AssureTech 面板浸入测试；AssureTech 快速杯测试；AssureTech 多药物尿液测试面板；AssureTech 多药物尿液测试杯 K243573FaStep 早期妊娠快速测试条；FaStep 早期妊娠快速测试卡式；FaStep 早期妊娠快速测试中段 K240351FaStep 芬太尼快速测试装置（尿液）；FaStep 快速芬太尼尿液测试（尿液）

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官方来源

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