Clearance Summary
BIOFIRE SPOTFIRE Respiratory (R) Panel received FDA 510(k) clearance under submission number K213954, sponsored by Biofire Diagnostics. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-02-03.
- Submission: K213954
- Applicant / Sponsor: Biofire Diagnostics
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3981
- Decision date: 2023-02-03
Classification & Regulation
This clearance is catalogued under FDA product code QOF and 21 CFR 866.3981, within the Microbiology review panel as a Class II device.