FDA 510(k)

FebriDx细菌/非细菌即时检测

K号: K230917 · 2023-06-30

决定日期2023-06-30

产品代码QXA

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决定实质等同

器械摘要

FebriDx Bacterial / Non-bacterial Point of Care 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 2023-06-30 under 510(k) number K230917. 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 Point of Care Assay?

FebriDx Bacterial / Non-bacterial Point of Care Assay is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Lumos Diagnostics, Inc.. The 510(k) number is K230917.

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

FebriDx Bacterial / Non-bacterial Point of Care Assay received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230917.

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

The FDA product code for FebriDx Bacterial / Non-bacterial Point of Care 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。

K260787FebriDx细菌/非细菌检测

官方来源

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