FilmArray NGDS Warrior Panel
FDA 510(k) clearance DEN160048 · decided 2017-02-14
Clearance details
- K-number
- DEN160048
- Device name
- FilmArray NGDS Warrior Panel
- Applicant
- Biofire Defense, LLC
- Decision
- Unknown
- Date received
- 2016-10-17
- Decision date
- 2017-02-14
- Days to decision
- 120 days
- Clearance type
- Direct
- Product code
- PRD
- Advisory committee
- Immunology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BioFire Warrior Panel; BioFire Warrior Panel Control Kit (K243822) | Biofire Defense, LLC | 2025-03-12 |
| FilmArray NGDS Warrior Panel (K170883) | Biofire Defense, LLC | 2017-06-22 |
Recalls involving this device
No recalls on record reference this clearance.