FDA 510(k)

AlphaID® 家庭遗传健康风险评估服务

K号: K221420 · 2022-10-27

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

决定日期2022-10-27

产品代码PTA

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决定实质等同

器械摘要

AlphaID™ At Home Genetic Health Risk Service 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 2022-10-27 under 510(k) number K221420. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AlphaID™ At Home Genetic Health Risk Service?

AlphaID™ At Home Genetic Health Risk Service is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is Progenika Biopharma S.A., A Grifols Company. The 510(k) number is K221420.

When did AlphaID™ At Home Genetic Health Risk Service receive FDA 510(k) clearance?

AlphaID™ At Home Genetic Health Risk Service received FDA 510(k) clearance on 2022-10-27, under 510(k) number K221420.

Who is the listed applicant for AlphaID™ At Home Genetic Health Risk Service?

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 AlphaID™ At Home Genetic Health Risk Service?

The FDA product code for AlphaID™ At Home Genetic Health Risk Service is PTA.

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。

K211115A1AT 基因分型测试 K192858A1AT 基因分型测试 K171868A1AT 基因分型测试

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