FDA 510(k)

CorDx Tyfast COVID-19 Ag 快速檢測；CorDx COVID-19 Ag 檢測

K 號：K240728 · 2024-06-21

決定日期2024-06-21

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

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is the device name listed in this FDA 510(k) record. The listed applicant is CorDx, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K240728. 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 CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is CorDx, Inc.. The 510(k) number is K240728.

When did CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test receive FDA 510(k) clearance?

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test received FDA 510(k) clearance on 2024-06-21, under 510(k) number K240728.

Who is the listed applicant for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

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

What is the FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

The FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is QYT.

其他以 CorDx, Inc. 為申請人之記錄

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K253882CorDx Tyfast COVID-19 Ag 快速檢測藥品許可證

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., LLC 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

官方來源

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