Clearance Summary
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) received FDA 510(k) clearance under submission number K163637, sponsored by Becton Dickinson & Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2017-03-21.
- Submission: K163637
- Applicant / Sponsor: Becton Dickinson & Company
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1645
- Decision date: 2017-03-21
Classification & Regulation
This clearance is catalogued under FDA product code LON and 21 CFR 866.1645, within the Microbiology review panel as a Class II device.