FDA 510(k)

FebriDx细菌/非细菌检测

K号: K260787 · 2026-03-24

决定日期2026-03-24

产品代码QXA

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决定实质等同

器械摘要

FebriDx Bacterial/Non-bacterial Assay is the device name listed in this FDA 510(k) record. The listed applicant is Lumos Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-03-24 under 510(k) number K260787. The device is classified under product code QXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FebriDx Bacterial/Non-bacterial Assay?

FebriDx Bacterial/Non-bacterial Assay is a medical device that received FDA 510(k) clearance on 2026-03-24. The listed applicant is Lumos Diagnostics, Inc.. The 510(k) number is K260787.

When did FebriDx Bacterial/Non-bacterial Assay receive FDA 510(k) clearance?

FebriDx Bacterial/Non-bacterial Assay received FDA 510(k) clearance on 2026-03-24, under 510(k) number K260787.

Who is the listed applicant for FebriDx Bacterial/Non-bacterial Assay?

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

What is the FDA product code for FebriDx Bacterial/Non-bacterial Assay?

The FDA product code for FebriDx Bacterial/Non-bacterial Assay is QXA.

列明Lumos 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。

K230917FebriDx细菌/非细菌即时检测

官方来源

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