Clearance Summary
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) received FDA 510(k) clearance under submission number K123903, sponsored by Becton, Dickinson & CO. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2013-05-13.
- Submission: K123903
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.2560
- Decision date: 2013-05-13
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.