FDA 510(k)

FilmArray 全球发热面板外部控制套件

K号: K202382 · 2020-11-20

决定日期2020-11-20

产品代码PMN

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决定实质等同

器械摘要

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.

常见问题

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)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 Global Fever Panel External Control Kit?

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

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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