FDA 510(k)

QNext 和 DG-PT

K 號：K183390 · 2019-08-21

決定日期2019-08-21

產品代碼JPA

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

QNext and DG-PT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Grifols, S.A.. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K183390. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QNext and DG-PT?

QNext and DG-PT is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Diagnostic Grifols, S.A.. The 510(k) number is K183390.

When did QNext and DG-PT receive FDA 510(k) clearance?

QNext and DG-PT received FDA 510(k) clearance on 2019-08-21, under 510(k) number K183390.

Who is the listed applicant for QNext and DG-PT?

The FDA 510(k) record lists Diagnostic Grifols, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QNext and DG-PT?

The FDA product code for QNext and DG-PT is JPA.

相關器械（代碼：JPA）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JPA）

官方來源