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FDA 510(k)

VITROS®自動化解決方案

K 號：K160495 · 2016-10-18

申請人Ortho-Clinical Diagnostics, Inc.
決定日期2016-10-18
產品代碼KLI
諮詢委員會CH
決定相當於

器材摘要

VITROS® Automation Solutions 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 2016-10-18 under 510(k) number K160495. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITROS® Automation Solutions?

VITROS® Automation Solutions is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K160495.

When did VITROS® Automation Solutions receive FDA 510(k) clearance?

VITROS® Automation Solutions received FDA 510(k) clearance on 2016-10-18, under 510(k) number K160495.

Who is the listed applicant for VITROS® Automation Solutions?

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® Automation Solutions?

The FDA product code for VITROS® Automation Solutions is KLI.

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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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