FDA 510(k)

Aptima HCV Quant Dx Assay

K号: K233352 · 2024-07-24

决定日期2024-07-24

产品代码MZP

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决定实质等同

器械摘要

Aptima HCV Quant Dx 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 2024-07-24 under 510(k) number K233352. The device is classified under product code MZP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aptima HCV Quant Dx Assay?

Aptima HCV Quant Dx Assay is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Hologic, Inc.. The 510(k) number is K233352.

When did Aptima HCV Quant Dx Assay receive FDA 510(k) clearance?

Aptima HCV Quant Dx Assay received FDA 510(k) clearance on 2024-07-24, under 510(k) number K233352.

Who is the listed applicant for Aptima HCV Quant Dx 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 Aptima HCV Quant Dx Assay?

The FDA product code for Aptima HCV Quant Dx Assay is MZP.

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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