FilmArray NGDS Warrior Panel
FDA 510(k) clearance K170883 · decided 2017-06-22
Clearance details
- K-number
- K170883
- Device name
- FilmArray NGDS Warrior Panel
- Applicant
- Biofire Defense, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-03-24
- Decision date
- 2017-06-22
- 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
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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 (DEN160048) | Biofire Defense, LLC | 2017-02-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArr recall (Z-2877-2026) | Biofire Defense | 2026-08-04 |
| FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-bas recall (Z-2609-2025) | Biofire Defense | 2025-09-19 |
| FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only recall (Z-1448-2020) | Biofire Defense | 2020-02-18 |