FDA 510(k)

Quo-Test A1c 系統

K 號：K180509 · 2019-02-16

決定日期2019-02-16

產品代碼LCP

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

Quo-Test A1c System is the device name listed in this FDA 510(k) record. The listed applicant is Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2019-02-16 under 510(k) number K180509. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quo-Test A1c System?

Quo-Test A1c System is a medical device that received FDA 510(k) clearance on 2019-02-16. The listed applicant is Ekf-Diagnostic GmbH. The 510(k) number is K180509.

When did Quo-Test A1c System receive FDA 510(k) clearance?

Quo-Test A1c System received FDA 510(k) clearance on 2019-02-16, under 510(k) number K180509.

Who is the listed applicant for Quo-Test A1c System?

The FDA 510(k) record lists Ekf-Diagnostic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quo-Test A1c System?

The FDA product code for Quo-Test A1c System is LCP.

其他以 Ekf-Diagnostic GmbH 為申請人之記錄

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相關器械（代碼：LCP）

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官方來源

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