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FDA 510(k)

SAFElife™ 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

K 號：K241741 · 2024-07-16

申請人Guangzhou Wondfo Biotech Co., Ltd.
決定日期2024-07-16
產品代碼NGL
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

SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 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 2024-07-16 under 510(k) number K241741. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel?

SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a medical device that received FDA 510(k) clearance on 2024-07-16. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K241741.

When did SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel receive FDA 510(k) clearance?

SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel received FDA 510(k) clearance on 2024-07-16, under 510(k) number K241741.

Who is the listed applicant for SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel?

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 SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel?

The FDA product code for SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is NGL.

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 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 DxK252550SAFElife T-Cup 多藥尿液檢測杯；SAFElife T-Cup 多藥尿液檢測杯 DxK251289WELLlife COVID-19 抗原檢測 藥品許可證K241317Wondfo 2019-nCoV 抗原檢測（橫向流測試法）K202567Wondfo T-Dip 多藥尿液檢測組合，Wondfo T-Dip 多藥尿液檢測組合 RxK182701Wondfo T-Cup 多藥尿液檢測杯

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相關器械（代碼：NGL）

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。

K253567Healgen精準尿液藥物檢測濾卡；Healgen精準家庭尿液藥物檢測濾卡Healgen Scientific,, LLCK250803Deepblue 多藥尿液檢測杯；Deepblue 家用多藥尿液檢測杯Anhui Deepblue Medical Technological Co., Ltd.K250067Dochek® 多藥尿液檢測杯；Dochek® 多藥尿液檢測杯 ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® 藥物濾尿試紙，Dochek® 藥物濾尿試紙加強版，Dochek® 藥物濾尿試卡，Dochek® 藥物濾尿試卡加強版，Dochek® 藥物濾尿試杯以及Dochek® 藥物濾尿試杯加強版Guangzhou Decheng Biotechnology Co., Ltd.K243365Healgen精準多藥尿液檢測杯；Healgen精準家庭多藥尿液檢測杯Healgen Scientific,, LLCK243064ETERBIO 藥物濃度快速檢測儀（膠體金）；ETERBIO 藥物濃度家庭檢測套件Eterbio, Inc.

官方來源

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