Clearance Summary
THREE LEVEL CONTROL SERA received FDA 510(k) clearance under submission number K810459, sponsored by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-08-03.
- Submission: K810459
- Applicant / Sponsor: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1981-08-03
Classification & Regulation
This clearance is catalogued under FDA product code DHX and 21 CFR 866.6010, within the Immunology review panel as a Class II device.