FDA 510(k)

證據 MultiSTAT 死亡尿多聯合

K 號：K250741 · 2026-01-23

決定日期2026-01-23

產品代碼DJG

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決定相當於

器材摘要

Evidence MultiSTAT DOA Urine MultiPlex 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 2026-01-23 under 510(k) number K250741. 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 DOA Urine MultiPlex is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Randox Laboratories Limited. The 510(k) number is K250741.

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

Evidence MultiSTAT DOA Urine MultiPlex received FDA 510(k) clearance on 2026-01-23, under 510(k) number K250741.

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

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?

The FDA product code for Evidence MultiSTAT DOA Urine MultiPlex 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。

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官方來源

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