FDA 510(k)

FilmArray 肺炎/肺炎plus 控制器

K 號：K190222 · 2019-05-03

申請人Maine Molecular Quality Controls, Inc.

決定日期2019-05-03

產品代碼PMN

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/Pneumoniaplus Control is the device name listed in this FDA 510(k) record. The listed applicant is Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190222. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FilmArray Pneumonia/Pneumoniaplus Control?

FilmArray Pneumonia/Pneumoniaplus Control is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K190222.

When did FilmArray Pneumonia/Pneumoniaplus Control receive FDA 510(k) clearance?

FilmArray Pneumonia/Pneumoniaplus Control received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190222.

Who is the listed applicant for FilmArray Pneumonia/Pneumoniaplus Control?

The FDA 510(k) record lists Maine Molecular Quality Controls, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FilmArray Pneumonia/Pneumoniaplus Control?

The FDA product code for FilmArray Pneumonia/Pneumoniaplus Control is PMN.

其他以 Maine Molecular Quality Controls, Inc. 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。

K260577FilmArray TF 控制面板 M527 K251526FilmArray GI Control Panel M238 K241289SPOTFIRE RSP 正負控制；SPOTFIRE RSP 負控制 K233611SPOTFIRE RSP 正負控制 (M425)，SPOTFIRE RSP 阳性控制 (M42638)，SPOTFIRE RSP 阴性控制 (M42738)K230868SPOTFIRE® RSP 正負控制，SPOTFIRE® RSP 阳性控制，SPOTFIRE® RSP 阴性控制 K221253SPOTFIRE RSP 正向控制，SPOTFIRE RSP 負向控制

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相關器械（代碼：PMN）

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。

K261475BIOFIRE® FILMARRAY® 熱帶熱症面板控制組Biofire Defense, LLC K260577FilmArray TF 控制面板 M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex 適用於BCPStreck, LLC K254166MDx-Chex 適用於BCNStreck K254167MDx-Chex用於BCY的醫療設備規範文本Streck, LLC K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.

官方來源

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