FDA 510(k)

Wondfo 2019-nCoV 抗原檢測（橫向流測試法）

K 號：K241317 · 2024-09-30

決定日期2024-09-30

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

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K241317. 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 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K241317.

When did Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) receive FDA 510(k) clearance?

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) received FDA 510(k) clearance on 2024-09-30, under 510(k) number K241317.

Who is the listed applicant for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

The FDA product code for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is QYT.

其他以 Guangzhou Wondfo Biotech Co., Ltd. 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。

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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。

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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