FDA 510(k)

ARCHITECT HSV-1 IgG，ARCHITECT HSV-1 IgG校准器，ARCHITECT HSV-1 IgG控制品

K号: K213987 · 2023-09-20

决定日期2023-09-20

产品代码MXJ

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决定实质等同

器械摘要

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls 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 2023-09-20 under 510(k) number K213987. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Biokit, S.A.. The 510(k) number is K213987.

When did ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls receive FDA 510(k) clearance?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls received FDA 510(k) clearance on 2023-09-20, under 510(k) number K213987.

Who is the listed applicant for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

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 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

The FDA product code for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is MXJ.

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 K214068Quantia IgE 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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