FebriDx Bacterial / Non-bacterial Point of Care Assay— 510(k) K230917

Name: FDA 510(k) clearance K230917
Creator: U.S. Food and Drug Administration
Published: 2023-06-30

Substantially Equivalent

Lumos Diagnostics, Inc.

FDA 510(k) clearance K230917 for FebriDx Bacterial / Non-bacterial Point of Care Assay, Substantially Equivalent on 2023-06-30. Applicant: Lumos Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Lumos Diagnostics, Inc.
Product code: Code QXA
Device class: Class 2
Regulation: 21 CFR 866.3230
Advisory panel: Microbiology
Date received: 2023-04-03
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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