Clearance Summary
TIGECYCLINE 15UG BBL SENSI-DISC received FDA 510(k) clearance under submission number K052853, 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 2005-11-17.
- Submission: K052853
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1620
- Decision date: 2005-11-17
Classification & Regulation
This clearance is catalogued under FDA product code JTN and 21 CFR 866.1620, within the Microbiology review panel as a Class II device.