FebriDx Bacterial/Non-bacterial Assay— 510(k) K260787
Substantially EquivalentLumos Diagnostics, Inc.
FDA 510(k) clearance K260787 for FebriDx Bacterial/Non-bacterial Assay, Substantially Equivalent on 2026-03-24. 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
- Dual Track
- Location
- Carlsbad, CA, US
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