FDA 510(k)

LZI Fentanyl III 酶免疫分析儀

K 號：K251634 · 2025-06-18

決定日期2025-06-18

產品代碼DJG

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

LZI Fentanyl III Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K251634. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LZI Fentanyl III Enzyme Immunoassay?

LZI Fentanyl III Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K251634.

When did LZI Fentanyl III Enzyme Immunoassay receive FDA 510(k) clearance?

LZI Fentanyl III Enzyme Immunoassay received FDA 510(k) clearance on 2025-06-18, under 510(k) number K251634.

Who is the listed applicant for LZI Fentanyl III Enzyme Immunoassay?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LZI Fentanyl III Enzyme Immunoassay?

The FDA product code for LZI Fentanyl III Enzyme Immunoassay is DJG.

其他以 Lin-Zhi International, Inc. 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。

K253082LZI Buprenorphine II 酶免疫分析 K202007LZI Oxycodone III 酶免疫分析 K201938LZI Fentanyl II 酶免疫分析儀 K201223LZI Tramadol 酶免疫分析儀 K192299LZI Cotinine II 酶免疫分析儀 K192433LZI美沙酮II酶免疫測試

查看所有 9 項裝置 →

相關器械（代碼：DJG）

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。

K252684Labcorp 藥物尿檢視測試Medtox Diagnostics, Inc.K250741證據 MultiSTAT 死亡尿多聯合Randox Laboratories Limited K253082LZI Buprenorphine II 酶免疫分析Lin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone 口服濃縮液Immunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)測試套件 - 定性；Healgen® 免疫荧光分析儀（OG-H180）Healgen Scientific,, LLC K240124BioSieve™ 藥物濃度快速檢測套件；BioSieve™ ToxiSmart FIA 閱讀器Vivachek Biotech (Hangzhou) Co., Ltd.

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。