DeviceClearance

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

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..

Clearance details

Applicant
Lumos Diagnostics, Inc.
Product code
Code QXA
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

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