FDA 510(k)

Accelerate 弧形系统

K号: K240854 · 2024-09-26

决定日期2024-09-26

产品代码QNJ

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决定实质等同

器械摘要

Accelerate Arc System is the device name listed in this FDA 510(k) record. The listed applicant is Accelerate Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K240854. The device is classified under product code QNJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Accelerate Arc System?

Accelerate Arc System is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Accelerate Diagnostics, Inc.. The 510(k) number is K240854.

When did Accelerate Arc System receive FDA 510(k) clearance?

Accelerate Arc System received FDA 510(k) clearance on 2024-09-26, under 510(k) number K240854.

Who is the listed applicant for Accelerate Arc System?

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

What is the FDA product code for Accelerate Arc System?

The FDA product code for Accelerate Arc System is QNJ.

列明Accelerate 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。

K192665Accelerate 现象系统，Accelerate PhenoTest BC 套件

官方来源

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