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FDA 510(k)

治康快速COVID-19抗原自測包

K 號：K260095 · 2026-04-13

申請人Healgen Scientific,, LLC
決定日期2026-04-13
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

Heal-Check Rapid COVID-19 Antigen Self-Test is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K260095. 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 Heal-Check Rapid COVID-19 Antigen Self-Test?

Heal-Check Rapid COVID-19 Antigen Self-Test is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K260095.

When did Heal-Check Rapid COVID-19 Antigen Self-Test receive FDA 510(k) clearance?

Heal-Check Rapid COVID-19 Antigen Self-Test received FDA 510(k) clearance on 2026-04-13, under 510(k) number K260095.

Who is the listed applicant for Heal-Check Rapid COVID-19 Antigen Self-Test?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heal-Check Rapid COVID-19 Antigen Self-Test?

The FDA product code for Heal-Check Rapid COVID-19 Antigen Self-Test is QYT.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Healgen Scientific,, 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。

K253705Healgen®精準口腔濾液藥物檢測K252523Healgen®精準口腔濾液藥物檢測COT/THC；Healgen®精準口腔濾液藥物檢測K251800Healgen® URS測試條K253567Healgen精準尿液藥物檢測濾卡；Healgen精準家庭尿液藥物檢測濾卡K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)測試套件 - 定性；Healgen® 免疫荧光分析儀（OG-H180）K243365Healgen精準多藥尿液檢測杯；Healgen精準家庭多藥尿液檢測杯

查看所有 15 項裝置 →

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。

K260754Fastep COVID-19 抗原筆式家庭檢測；Fastep COVID-19 抗原筆式檢測Assure Tech., LLCK251916GenBody 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, LLCK243518BinaxNOW™ COVID-19 抗原自測包Abbott Diagnostics Scarborough, Inc.

官方來源

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