FDA 510(k)

PBC 分离器与Selux AST 系统

K号: K244044 · 2025-03-28

决定日期2025-03-28

产品代码QZX

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决定实质等同

器械摘要

PBC Separator with Selux AST System is the device name listed in this FDA 510(k) record. The listed applicant is Selux Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-03-28 under 510(k) number K244044. The device is classified under product code QZX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PBC Separator with Selux AST System?

PBC Separator with Selux AST System is a medical device that received FDA 510(k) clearance on 2025-03-28. The listed applicant is Selux Diagnostics, Inc.. The 510(k) number is K244044.

When did PBC Separator with Selux AST System receive FDA 510(k) clearance?

PBC Separator with Selux AST System received FDA 510(k) clearance on 2025-03-28, under 510(k) number K244044.

Who is the listed applicant for PBC Separator with Selux AST System?

The FDA 510(k) record lists Selux Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PBC Separator with Selux AST System?

The FDA product code for PBC Separator with Selux AST System is QZX.

列明Selux Diagnostics, Inc.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。

K223493PBC 分离器与Selux AST 系统 K211748Selux AST系统；型号AST Gen 1.0 K211759Selux AST系统；型号AST Gen 1.0

官方来源

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