FebriDx Bacterial/Non-bacterial Assay
FDA 510(k) clearance K260787 · decided 2026-03-24
Clearance details
- K-number
- K260787
- Device name
- FebriDx Bacterial/Non-bacterial Assay
- Applicant
- Lumos Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-10
- Decision date
- 2026-03-24
- Days to decision
- 14 days
- Clearance type
- Dual Track
- Product code
- QXA
- Device class
- 2
- Regulation number
- 866.3230
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FebriDx Bacterial / Non-bacterial Point of Care Assay (K230917) | Lumos Diagnostics, Inc. | 2023-06-30 |
Recalls involving this device
No recalls on record reference this clearance.