FDA 510(k)

FilmArray全球發燒面板外部控制組合包

K 號：K202382 · 2020-11-20

決定日期2020-11-20

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 Global Fever Panel External Control Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K202382. 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 Global Fever Panel External Control Kit?

FilmArray Global Fever Panel External Control Kit is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Biofire Defense, LLC. The 510(k) number is K202382.

When did FilmArray Global Fever Panel External Control Kit receive FDA 510(k) clearance?

FilmArray Global Fever Panel External Control Kit received FDA 510(k) clearance on 2020-11-20, under 510(k) number K202382.

Who is the listed applicant for FilmArray Global Fever Panel External Control Kit?

FDA 510(k) 記錄將 Biofire Defense, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for FilmArray Global Fever Panel External Control Kit?

The FDA product code for FilmArray Global Fever Panel External Control Kit is PMN.

其他以 Biofire Defense, 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。

K261475BIOFIRE® FILMARRAY® 熱帶熱症面板控制組 K243822BioFire戰士面板；BioFire戰士面板控制套件 K213362BioFire Global 還熱特殊病原體面板；BIOFIRE SHIELD 控制組合用於BioFire Global 還熱特殊病原體面板 K220870BioFire Global 還熱試劑板，BIOFIRE SHIELD 控制組合用於BioFire Global 還熱試劑板 K221460生物火COVID-19測試2 K211079生物火COVID-19測試2

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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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