510(k) K230917
- Device
- FebriDx Bacterial / Non-bacterial Point of Care Assay
- Applicant
- Lumos Diagnostics, Inc.
- 510(k) number
- K230917
- Product code
- QXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-30
- Date received
- 2023-04-03
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sue Hibbeln
- Address
- 2724 Loker Ave. 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 |
|---|---|---|---|
| K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | 2026-03-24 |