FDA 510(k)

FilmArray 肺炎檢測組合 plus

K 號：K181324 · 2018-11-15

決定日期2018-11-15

產品代碼QDS

諮詢委員會PA

決定相當於

器材摘要

FilmArray Pneumonia Panel plus 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 2018-11-15 under 510(k) number K181324. The device is classified under product code QDS. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FilmArray Pneumonia Panel plus?

FilmArray Pneumonia Panel plus is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K181324.

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

FilmArray Pneumonia Panel plus received FDA 510(k) clearance on 2018-11-15, under 510(k) number K181324.

Who is the listed applicant for FilmArray Pneumonia Panel plus?

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 plus?

The FDA product code for FilmArray Pneumonia Panel plus is QDS.

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。

K243544BIOFIRE SPOTFIRE 呼吸道/喉痛面板迷你版 K243885BIOFIRE FILMARRAY 消化道（GI）面板中 K243759BIOFIRE 血培養識別 2 (BCID2) 面板 (RFIT-ASY-0147 (30 套) RFIT-ASY-0148 (6 套))K242367BIOFIRE FILMARRAY 消化道（GI）面板 K241194BIOFIRE SPOTFIRE 呼吸道/喉痛（R/ST）面板迷你版 K232954BIOFIRE SPOTFIRE 呼吸道/喉痛（R/ST）面板

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相關器械（代碼：QDS）

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。

K243222BIOFIRE® FILMARRAY® 肺炎檢測組合（BIOFIRE 肺炎檢測組合）；BIOFIRE® FILMARRAY® 肺炎檢測組合加值版（BIOFIRE 肺炎檢測組合加值版）Biofire Diagnostics, LLC (Biomerieux)K222601FilmArray 肺炎檢測組合 plusBiofire Diagnostics, LLC

官方來源

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