FDA 510(k)

LZI Buprenorphine II 酶免疫分析

K 號：K253082 · 2026-01-16

決定日期2026-01-16

產品代碼DJG

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決定相當於

器材摘要

LZI Buprenorphine II 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 2026-01-16 under 510(k) number K253082. 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 Buprenorphine II Enzyme Immunoassay?

LZI Buprenorphine II Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K253082.

When did LZI Buprenorphine II Enzyme Immunoassay receive FDA 510(k) clearance?

LZI Buprenorphine II Enzyme Immunoassay received FDA 510(k) clearance on 2026-01-16, under 510(k) number K253082.

Who is the listed applicant for LZI Buprenorphine II 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 Buprenorphine II Enzyme Immunoassay?

The FDA product code for LZI Buprenorphine II 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。

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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 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 K251634LZI Fentanyl III 酶免疫分析儀Lin-Zhi International, Inc.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

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