Clearance Summary
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 received FDA 510(k) clearance under submission number K143005, sponsored by Biofire Diagnostics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2015-02-19.
- Submission: K143005
- Applicant / Sponsor: Biofire Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3990
- Decision date: 2015-02-19
Classification & Regulation
This clearance is catalogued under FDA product code PCH and 21 CFR 866.3990, within the Microbiology review panel as a Class II device.