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FDA 510(k)

免疫球蛋白同种型（GAM）用于EXENT分析器；EXENT分析器

K号: K250159 · 2025-10-17

申请人The Binding Site Group , Ltd.
决定日期2025-10-17
产品代码SGG
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决定实质等同

器械摘要

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250159. The device is classified under product code SGG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K250159.

When did Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser receive FDA 510(k) clearance?

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250159.

Who is the listed applicant for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

The FDA product code for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is SGG.

相关临床试验

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列明The Binding Site Group , Ltd.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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