FDA 510(k)

Quantia IgE

K号: K214068 · 2023-02-21

决定日期2023-02-21

产品代码DGC

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决定实质等同

器械摘要

Quantia IgE is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2023-02-21 under 510(k) number K214068. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantia IgE?

Quantia IgE is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Biokit, S.A.. The 510(k) number is K214068.

When did Quantia IgE receive FDA 510(k) clearance?

Quantia IgE received FDA 510(k) clearance on 2023-02-21, under 510(k) number K214068.

Who is the listed applicant for Quantia IgE?

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

What is the FDA product code for Quantia IgE?

The FDA product code for Quantia IgE is DGC.

列明Biokit, S.A.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。

K243575ARCHITECT HSV-2 IgG，ARCHITECT HSV-2 IgG校准器，ARCHITECT HSV-2 IgG控制品 K233606ADVIA Centaur EBV-VCA IgM K233605ADVIA Centaur EBV-EBNA IgG K213987ARCHITECT HSV-1 IgG，ARCHITECT HSV-1 IgG校准器，ARCHITECT HSV-1 IgG控制品 K181334ADVIA Centaur 单纯疱疹病毒2型IgG K181333ADVIA Centaur 单纯疱疹病毒1型IgG

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。