510(k) K260787
- Device
- FebriDx Bacterial/Non-bacterial Assay
- Applicant
- Lumos Diagnostics, Inc.
- 510(k) number
- K260787
- Product code
- QXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-24
- Date received
- 2026-03-10
- Regulation
- 866.3230
- Classification name
- Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Dual Track
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Susan Hibbeln
- Address
- 2724 Loker Ave. W. Carlsbad CA US 92010 92010
FDA Registration Numbers#
- 3006602209
Source Documents#
Other 510(k) Records For Product Code QXA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230917 | FebriDx Bacterial / Non-bacterial Point of Care Assay | Lumos Diagnostics, Inc. | 2023-06-30 |