FDA 510(k)

LZI Fentanyl II 酶免疫分析儀

K 號：K201938 · 2020-08-07

決定日期2020-08-07

產品代碼DJG

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決定相當於

器材摘要

LZI Fentanyl 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 2020-08-07 under 510(k) number K201938. 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 II Enzyme Immunoassay?

LZI Fentanyl II Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K201938.

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

LZI Fentanyl II Enzyme Immunoassay received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201938.

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

The FDA product code for LZI Fentanyl 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 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 K251634LZI Fentanyl III 酶免疫分析儀Lin-Zhi International, Inc.

官方來源

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