Clearance Summary
FilmArray NGDS Warrior Panel received FDA 510(k) clearance under submission number K170883, sponsored by Biofire Defense, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2017-06-22.
- Submission: K170883
- Applicant / Sponsor: Biofire Defense, LLC
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class:
- Decision date: 2017-06-22
Classification & Regulation
This clearance is catalogued under FDA product code PRD , within the Immunology review panel as a device.