FDA 510(k)

LifeScale 革兰氏阴性试剂盒（LSGN）与 LifeScale AST 系统

K号: K241324 · 2024-10-23

决定日期2024-10-23

产品代码SAN

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决定实质等同

器械摘要

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is the device name listed in this FDA 510(k) record. The listed applicant is Affinity Biosensors, LLC. It received FDA 510(k) clearance on 2024-10-23 under 510(k) number K241324. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is Affinity Biosensors, LLC. The 510(k) number is K241324.

When did LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system receive FDA 510(k) clearance?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system received FDA 510(k) clearance on 2024-10-23, under 510(k) number K241324.

Who is the listed applicant for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system?

The FDA 510(k) record lists Affinity Biosensors, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system?

The FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is SAN.

列明Affinity Biosensors, LLC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。

K251875LifeScale 革兰氏阴性试剂盒（LSGN）与 LifeScale AST 系统

官方来源

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