FDA 510(k)

FilmArray NGDS 戰士面板

K 號：K170883 · 2017-06-22

決定日期2017-06-22

產品代碼PRD

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

FilmArray NGDS Warrior Panel 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 2017-06-22 under 510(k) number K170883. The device is classified under product code PRD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FilmArray NGDS Warrior Panel?

FilmArray NGDS Warrior Panel is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Biofire Defense, LLC. The 510(k) number is K170883.

When did FilmArray NGDS Warrior Panel receive FDA 510(k) clearance?

FilmArray NGDS Warrior Panel received FDA 510(k) clearance on 2017-06-22, under 510(k) number K170883.

Who is the listed applicant for FilmArray NGDS Warrior Panel?

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 NGDS Warrior Panel?

The FDA product code for FilmArray NGDS Warrior Panel is PRD.