FDA Product Code
FDA Product Code QXA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3230
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | 2026-03-24 | Dual Track | PDF ↗ |
| K230917 | FebriDx Bacterial / Non-bacterial Point of Care Assay | Lumos Diagnostics, Inc. | 2023-06-30 | Traditional | PDF ↗ |
Product code QXA · Class II · Microbiology. Data: openFDA.