Clearance Summary
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial received FDA 510(k) clearance under submission number K161810, sponsored by Becton Dickinson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2017-02-09.
- Submission: K161810
- Applicant / Sponsor: Becton Dickinson
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.2560
- Decision date: 2017-02-09
Classification & Regulation
This clearance is catalogued under FDA product code MDB and 21 CFR 866.2560, within the Microbiology review panel as a Class I device.