Clearance Summary
BD Veritor System Flu A+B Assay received FDA 510(k) clearance under submission number K133138, sponsored by Becton, Dickinson & CO. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2013-11-13.
- Submission: K133138
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3328
- Decision date: 2013-11-13
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.