FDA 510(k)

Fastep COVID-19 抗原筆式家庭檢測；Fastep COVID-19 抗原筆式檢測

K 號：K260754 · 2026-06-05

決定日期2026-06-05

產品代碼QYT

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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) 記錄將 Assure Tech., LLC 列為申請人。這並不單獨確立設備製造商。

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.

其他以 Assure Tech., LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261984AssureTech 快速測試杯；AssureTech 多藥尿液測試杯 K252259AssureTech 快速杯測試；AssureTech 多藥尿液測試杯 K250117法斯特孕檢快速測試條；Fastep人類絲裂原子基因(HCG)快速測試條 K243996AssureTech Panel 測試劑；AssureTech 快速杯測試；AssureTech 多藥尿液測試面板；AssureTech 多藥尿液測試杯 K243573法斯特早期懷孕快速測試條；法斯特早期懷孕快速測試卡式；法斯特早期懷孕快速測試中間流 K240351法步芬太尼快速檢測儀（尿液）；法步芬太尼尿液快速檢測（尿液）

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相關器械（代碼：QYT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260095治康快速COVID-19抗原自測包Healgen Scientific,, LLC K251916GenBody COVID-19 Ag 家庭檢測Genbody.Inc.K251595COVID-19 快速自測檢測器InBios International, Inc.K251753GenaCheck COVID-19 快速自測包Genabio Diagnostics, Inc.K241313OHC COVID-19 抗原自測包Osang, LLC K243518BinaxNOW™ COVID-19 抗原自測包Abbott Diagnostics Scarborough, Inc.

官方來源

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