BioFire Warrior Panel; BioFire Warrior Panel Control Kit
FDA 510(k) clearance K243822 · decided 2025-03-12
Clearance details
- K-number
- K243822
- Device name
- BioFire Warrior Panel; BioFire Warrior Panel Control Kit
- Applicant
- Biofire Defense, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-12-12
- Decision date
- 2025-03-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PRD
- Advisory committee
- Immunology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biofire Defense
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 |
|---|---|---|
| FilmArray NGDS Warrior Panel (K170883) | Biofire Defense, LLC | 2017-06-22 |
| FilmArray NGDS Warrior Panel (DEN160048) | Biofire Defense, LLC | 2017-02-14 |
Recalls involving this device
No recalls on record reference this clearance.