Clearance Summary
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit received FDA 510(k) clearance under submission number K150815, sponsored by Becton, Dickinson and Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2015-12-17.
- Submission: K150815
- Applicant / Sponsor: Becton, Dickinson and Company
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2015-12-17
Classification & Regulation
This clearance is catalogued under FDA product code PMG and 21 CFR 864.5220, within the Hematology review panel as a Class II device.