FDA 510(k)

FilmArray 肺炎面板

K 號：K212727 · 2021-09-22

決定日期2021-09-22

產品代碼QDP

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

FilmArray Pneumonia Panel is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K212727. The device is classified under product code QDP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FilmArray Pneumonia Panel?

FilmArray Pneumonia Panel is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K212727.

When did FilmArray Pneumonia Panel receive FDA 510(k) clearance?

FilmArray Pneumonia Panel received FDA 510(k) clearance on 2021-09-22, under 510(k) number K212727.

Who is the listed applicant for FilmArray Pneumonia Panel?

The FDA 510(k) record lists Biofire Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FilmArray Pneumonia Panel?

The FDA product code for FilmArray Pneumonia Panel is QDP.

其他以 Biofire Diagnostics, LLC 為申請人之記錄

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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相關器械（代碼：QDP）

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。

K180966FilmArray 肺炎面板Biofire Diagnostics, LLC

官方來源

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