FDA 510(k)

EliA SymphonyS 免疫测定

K号: K190710 · 2019-11-29

决定日期2019-11-29

产品代码LLL

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决定实质等同

器械摘要

EliA SymphonyS Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2019-11-29 under 510(k) number K190710. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EliA SymphonyS Immunoassay?

EliA SymphonyS Immunoassay is a medical device that received FDA 510(k) clearance on 2019-11-29. The listed applicant is Phadia AB. The 510(k) number is K190710.

When did EliA SymphonyS Immunoassay receive FDA 510(k) clearance?

EliA SymphonyS Immunoassay received FDA 510(k) clearance on 2019-11-29, under 510(k) number K190710.

Who is the listed applicant for EliA SymphonyS Immunoassay?

The FDA 510(k) record lists Phadia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EliA SymphonyS Immunoassay?

The FDA product code for EliA SymphonyS Immunoassay is LLL.

列明Phadia AB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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