免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Healgen®精準芬太尼快速測試條（尿液）；Healgen®精準快速芬太尼測試條（尿液）；Healgen®精準芬太尼快速測試濾卡（尿液）；Healgen®精準快速芬太尼測試濾卡（尿液）；Healgen®精準芬太尼快速測試條（尿液）；Healgen®精準快速芬太尼測試條（尿液）

K 號：K240949 · 2024-05-13

申請人Healgen Scientific,, LLC
決定日期2024-05-13
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

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) 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 2024-05-13 under 510(k) number K240949. 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 Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)?

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K240949.

When did Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) receive FDA 510(k) clearance?

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) received FDA 510(k) clearance on 2024-05-13, under 510(k) number K240949.

Who is the listed applicant for Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)?

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 Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)?

The FDA product code for Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) 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 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。

K260095治康快速COVID-19抗原自測包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K253567Healgen精準尿液藥物檢測濾卡；Healgen精準家庭尿液藥物檢測濾卡K251800Healgen® URS測試條K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)測試套件 - 定性；Healgen® 免疫荧光分析儀（OG-H180）

查看所有 15 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑