Clearance Summary
BD Veritor (TM) System for the Rapid Detection of Flu A+B received FDA 510(k) clearance under submission number K151291, sponsored by Becton, Dickinson and Company. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2015-06-10.
- Submission: K151291
- Applicant / Sponsor: Becton, Dickinson and Company
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3328
- Decision date: 2015-06-10
Classification & Regulation
This clearance is catalogued under FDA product code PSZ and 21 CFR 866.3328, within the Microbiology review panel as a Class II device.