FebriDx Bacterial / Non-bacterial Point of Care Assay
FDA 510(k) clearance K230917 · decided 2023-06-30
Clearance details
- K-number
- K230917
- Device name
- FebriDx Bacterial / Non-bacterial Point of Care Assay
- Applicant
- Lumos Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-03
- Decision date
- 2023-06-30
- Days to decision
- 88 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Lumos Diagnostics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 Assay (K260787) | Lumos Diagnostics, Inc. | 2026-03-24 |
Recalls involving this device
No recalls on record reference this clearance.