FDA 510(k)

證據多項測試尿檢MultiSTAT，證據多項測試MultiSTAT

K 號：K220451 · 2023-10-05

決定日期2023-10-05

產品代碼DJG

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決定相當於

器材摘要

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K220451. 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 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT?

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Randox Laboratories Limited. The 510(k) number is K220451.

When did Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT receive FDA 510(k) clearance?

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT received FDA 510(k) clearance on 2023-10-05, under 510(k) number K220451.

Who is the listed applicant for Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT?

The FDA 510(k) record lists Randox Laboratories Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT?

The FDA product code for Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT is DJG.

其他以 Randox Laboratories Limited 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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