FDA 510(k)

A1AT 基因分型测试

K号: K211115 · 2021-05-13

申请人Progenika Biopharma S.A., A Grifols Company

决定日期2021-05-13

产品代码PZH

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决定实质等同

器械摘要

A1AT Genotyping Test is the device name listed in this FDA 510(k) record. The listed applicant is Progenika Biopharma S.A., A Grifols Company. It received FDA 510(k) clearance on 2021-05-13 under 510(k) number K211115. The device is classified under product code PZH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the A1AT Genotyping Test?

A1AT Genotyping Test is a medical device that received FDA 510(k) clearance on 2021-05-13. The listed applicant is Progenika Biopharma S.A., A Grifols Company. The 510(k) number is K211115.

When did A1AT Genotyping Test receive FDA 510(k) clearance?

A1AT Genotyping Test received FDA 510(k) clearance on 2021-05-13, under 510(k) number K211115.

Who is the listed applicant for A1AT Genotyping Test?

The FDA 510(k) record lists Progenika Biopharma S.A., A Grifols Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A1AT Genotyping Test?

The FDA product code for A1AT Genotyping Test is PZH.

列明Progenika Biopharma S.A., A Grifols Company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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