Clearance Summary
FilmArray Pneumonia Panel plus received FDA 510(k) clearance under submission number K181324, sponsored by Biofire Diagnostics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2018-11-15.
- Submission: K181324
- Applicant / Sponsor: Biofire Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 866.4001
- Decision date: 2018-11-15
Classification & Regulation
This clearance is catalogued under FDA product code QDS and 21 CFR 866.4001, within the Pathology review panel as a Class II device.