FDA 510(k)

VITROS XT 化學產品 TBIL-ALKP 製片

K 號：K190807 · 2019-04-26

決定日期2019-04-26

產品代碼CIG

諮詢委員會CH

決定相當於

器材摘要

VITROS XT Chemistry Products TBIL-ALKP 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 2019-04-26 under 510(k) number K190807. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITROS XT Chemistry Products TBIL-ALKP Slides?

VITROS XT Chemistry Products TBIL-ALKP Slides is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190807.

When did VITROS XT Chemistry Products TBIL-ALKP Slides receive FDA 510(k) clearance?

VITROS XT Chemistry Products TBIL-ALKP Slides received FDA 510(k) clearance on 2019-04-26, under 510(k) number K190807.

Who is the listed applicant for VITROS XT Chemistry Products TBIL-ALKP 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 TBIL-ALKP Slides?

The FDA product code for VITROS XT Chemistry Products TBIL-ALKP Slides is CIG.

其他以 Ortho-Clinical Diagnostics, Inc. 為申請人之記錄

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相關器械（代碼：CIG）

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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