FDA 510(k)

STA® - Liatest® D-Di

K 號：K162227 · 2016-12-10

決定日期2016-12-10

產品代碼DAP

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

STA® - Liatest® D-Di is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago. It received FDA 510(k) clearance on 2016-12-10 under 510(k) number K162227. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STA® - Liatest® D-Di?

STA® - Liatest® D-Di is a medical device that received FDA 510(k) clearance on 2016-12-10. The listed applicant is Diagnostica Stago. The 510(k) number is K162227.

When did STA® - Liatest® D-Di receive FDA 510(k) clearance?

STA® - Liatest® D-Di received FDA 510(k) clearance on 2016-12-10, under 510(k) number K162227.

Who is the listed applicant for STA® - Liatest® D-Di?

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

What is the FDA product code for STA® - Liatest® D-Di?

The FDA product code for STA® - Liatest® D-Di is DAP.

相關器械（代碼：DAP）

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K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbH K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO K160885HemosIL D-Dimer HSInstrumentation Laboratory CO

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：DAP）

官方來源