Clearance Summary
BD CTGCTV2 received FDA 510(k) clearance under submission number K243343, sponsored by Bd Integrated Diagnostic Solutions/Becton,. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-04-22.
- Submission: K243343
- Applicant / Sponsor: Bd Integrated Diagnostic Solutions/Becton,
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3393
- Decision date: 2025-04-22
Classification & Regulation
This clearance is catalogued under FDA product code QEP and 21 CFR 866.3393, within the Microbiology review panel as a Class II device.