FDA 510(k)

Healgen精準尿液藥物檢測濾卡；Healgen精準家庭尿液藥物檢測濾卡

K 號：K253567 · 2025-12-23

決定日期2025-12-23

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 Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card 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 2025-12-23 under 510(k) number K253567. 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 Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card?

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K253567.

When did Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card receive FDA 510(k) clearance?

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253567.

Who is the listed applicant for Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card?

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 Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card?

The FDA product code for Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card is NGL.

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 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）K243365Healgen精準多藥尿液檢測杯；Healgen精準家庭多藥尿液檢測杯

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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。

K250803Deepblue 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,, LLC K243064ETERBIO 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.K242802CLUNGENE 藥物濟用試劑盒；CLUNGENE 藥物測試劑盒Hangzhou Clongene Biotech Co., Ltd.

官方來源

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