FDA 510(k)

Wondfo T-Dip 多藥尿液檢測組合，Wondfo T-Dip 多藥尿液檢測組合 Rx

K 號：K202567 · 2020-09-25

決定日期2020-09-25

產品代碼NFT

諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。

決定相當於

器材摘要

Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 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 2020-09-25 under 510(k) number K202567. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx?

Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K202567.

When did Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx receive FDA 510(k) clearance?

Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx received FDA 510(k) clearance on 2020-09-25, under 510(k) number K202567.

Who is the listed applicant for Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx?

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 T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx?

The FDA product code for Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx is NFT.

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。

K260065SAFElife T-Dip 多藥尿液檢測組合；SAFElife T-Dip 多藥尿液檢測組合 Dx K252550SAFElife T-Cup 多藥尿液檢測杯；SAFElife T-Cup 多藥尿液檢測杯 Dx K251289WELLlife COVID-19 抗原檢測藥品許可證 K241317Wondfo 2019-nCoV 抗原檢測（橫向流測試法）K241741SAFElife™ 藥物尿檢測儀（試劑條）；SAFElife™ 藥物（FTY）尿檢測試劑條；SAFElife™ T-Dip 藥物尿檢測儀（滴測卡）；SAFElife™ T-Dip 藥物（FTY）尿檢測試劑板 K182701Wondfo T-Cup 多藥尿液檢測杯

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相關器械（代碼：NFT）

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。

K261409BioTeke® 多藥尿液檢測杯Bioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech 快速測試杯；AssureTech 多藥尿液測試杯Assure Tech., LLC K261280生物篩多藥尿液檢測組合；生物篩多藥尿液家庭檢測組合Vivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip 多藥尿液檢測組合；SAFElife T-Dip 多藥尿液檢測組合 DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest 多藥尿液杯；Webest 家用多藥尿液杯WEBEST Biotech,, LLC K252550SAFElife T-Cup 多藥尿液檢測杯；SAFElife T-Cup 多藥尿液檢測杯 DxGuangzhou Wondfo Biotech Co., Ltd.

官方來源

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