Clearance Summary
BD MAX CTGCTV2, BD MAX System received FDA 510(k) clearance under submission number K182692, sponsored by Becton, Dickinson and Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2019-01-08.
- Submission: K182692
- Applicant / Sponsor: Becton, Dickinson and Company
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.3860
- Decision date: 2019-01-08
Classification & Regulation
This clearance is catalogued under FDA product code OUY and 21 CFR 866.3860, within the Immunology review panel as a Class II device.