Medical Device Manufacturer · US , Carlsbad , CA

Lumos Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied

Lumos Diagnostics, Inc. has 2 FDA 510(k) cleared medical devices. Based in Carlsbad, US.

Latest FDA clearance: Mar 2026. Active since 2023. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Lumos Diagnostics, Inc. Filter by specialty or product code using the sidebar.

1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Lumos Diagnostics, Inc.
2 devices
1-2 of 2
Cleared Mar 24, 2026
FebriDx Bacterial/Non-bacterial Assay
K260787 · QXA
Microbiology · 14d
Cleared CT Jun 30, 2023
FebriDx Bacterial / Non-bacterial Point of Care Assay
K230917 · QXA
Microbiology · 88d
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