FDA 510(k)

FilmArray NGDS 战士面板

K号: K170883 · 2017-06-22

决定日期2017-06-22

产品代码PRD

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决定实质等同

器械摘要

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.

常见问题

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)记录显示，Biofire Defense, LLC为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for FilmArray NGDS Warrior Panel?

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

列明Biofire Defense, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261475BIOFIRE® FILMARRAY® 热带发热检测控制试剂盒 K243822BioFire 战士面板；BioFire 战士面板控制试剂盒 K213362BioFire 全球发热特殊病原体面板；BioFire SHIELD 控制试剂盒用于 BioFire 全球发热特殊病原体面板 K220870BioFire 全球发热面板，BioFire SHIELD 控制试剂盒用于 BioFire 全球发热面板 K221460BioFire COVID-19 测试 2 K211079BioFire COVID-19 测试 2

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官方来源

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