VITROS XT化學產品 UREA-CREA薄片
K 號：K190326 · 2019-03-14
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器材摘要
VITROS XT Chemistry Products UREA-CREA Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K190326. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VITROS XT Chemistry Products UREA-CREA Slides?
VITROS XT Chemistry Products UREA-CREA Slides is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190326.
When did VITROS XT Chemistry Products UREA-CREA Slides receive FDA 510(k) clearance?
VITROS XT Chemistry Products UREA-CREA Slides received FDA 510(k) clearance on 2019-03-14, under 510(k) number K190326.
Who is the listed applicant for VITROS XT Chemistry Products UREA-CREA Slides?
The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VITROS XT Chemistry Products UREA-CREA Slides?
The FDA product code for VITROS XT Chemistry Products UREA-CREA Slides is CDN.
相關臨床試驗
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其他以 Ortho-Clinical Diagnostics, 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。
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。
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