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FDA 510(k)

FilmArray 膿腦炎（ME）面板，與 FilmArray Torch 配合使用

K 號：K160462 · 2016-03-17

申請人Biofire Diagnostics, LLC
決定日期2016-03-17
產品代碼PLO
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 Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch 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 2016-03-17 under 510(k) number K160462. The device is classified under product code PLO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch?

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K160462.

When did FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch receive FDA 510(k) clearance?

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch received FDA 510(k) clearance on 2016-03-17, under 510(k) number K160462.

Who is the listed applicant for FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch?

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 Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch?

The FDA product code for FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch is PLO.

相關臨床試驗

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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：PLO）

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。

K242256QIAstat-Dx 脊髓腦膜炎/腦炎（ME）面板QIAGEN GmbHK190219Simplexa VZV Direct，Simplexa VZV 正規化試劑包Diasorin Molecular, LLC

官方來源

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