BioFire Warrior Panel; BioFire Warrior Panel Control Kit
FDA 510(k) K243822 · Biofire Defense, LLC
510(k) numberK243822
Submission
- Device name
- BioFire Warrior Panel; BioFire Warrior Panel Control Kit
- Applicant
- Biofire Defense, LLC
Salt Lake City, UT, US - Received
- December 12, 2024
- Decision date
- March 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
Other 510(k)s with product code PRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170883 | FilmArray NGDS Warrior PanelPRD · Traditional | Biofire Defense, LLC | 06/22/2017SE |
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| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional | 07/17/2026SE |
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| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelQMV · Traditional | 10/20/2022SE |
| K221460 | BioFire COVID-19 Test 2QQX · Special | 07/25/2022SE |
| K211079 | BioFire COVID-19 Test 2QQX · Traditional | 11/01/2021SE |
| K202382 | FilmArray Global Fever Panel External Control KitPMN · Traditional | 11/20/2020SE |
| K170883 | FilmArray NGDS Warrior PanelPRD · Traditional | 06/22/2017SE |
Questions and answers
When was BioFire Warrior Panel; BioFire Warrior Panel Control Kit cleared by the FDA?
BioFire Warrior Panel; BioFire Warrior Panel Control Kit (K243822) received a 510(k) decision of Substantially Equivalent on March 12, 2025, 90 days after the submission was received.