FDA 510(k)

Xpert® FII & FV

K 號：K223046 · 2023-02-15

決定日期2023-02-15

產品代碼NPR

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

Xpert® FII & FV is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K223046. The device is classified under product code NPR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert® FII & FV?

Xpert® FII & FV is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Cepheid®. The 510(k) number is K223046.

When did Xpert® FII & FV receive FDA 510(k) clearance?

Xpert® FII & FV received FDA 510(k) clearance on 2023-02-15, under 510(k) number K223046.

Who is the listed applicant for Xpert® FII & FV?

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

What is the FDA product code for Xpert® FII & FV?

The FDA product code for Xpert® FII & FV is NPR.

其他以 Cepheid® 為申請人之記錄

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相關器械（代碼：NPR）

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。

K250218Xpert® FII & FVCepheid K172913cobas 因子II及因子V檢測Roche Molecular Systems, Inc.

官方來源

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