FDA 510(k)

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

K号: K242465 · 2024-11-15

决定日期2024-11-15

产品代码QOF

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决定实质等同

器械摘要

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K242465. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Hologic, Inc.. The 510(k) number is K242465.

When did Panther Fusion SARS-CoV-2/Flu A/B/RSV assay receive FDA 510(k) clearance?

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA 510(k) clearance on 2024-11-15, under 510(k) number K242465.

Who is the listed applicant for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

FDA 510(k)记录中列出了Hologic, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

The FDA product code for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is QOF.

列明Hologic, Inc.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。

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