FDA 510(k)

FilmArray 呼吸面板 2 (RP2)

K 號：K170604 · 2017-05-30

決定日期2017-05-30

產品代碼OCC

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 Respiratory Panel 2 (RP2) 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 2017-05-30 under 510(k) number K170604. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FilmArray Respiratory Panel 2 (RP2)?

FilmArray Respiratory Panel 2 (RP2) is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K170604.

When did FilmArray Respiratory Panel 2 (RP2) receive FDA 510(k) clearance?

FilmArray Respiratory Panel 2 (RP2) received FDA 510(k) clearance on 2017-05-30, under 510(k) number K170604.

Who is the listed applicant for FilmArray Respiratory Panel 2 (RP2)?

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 Respiratory Panel 2 (RP2)?

The FDA product code for FilmArray Respiratory Panel 2 (RP2) is OCC.

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：OCC）

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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官方來源

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