Clearance Summary
TBM-REAGENT FOR T,B CELL & MONOCYTES received FDA 510(k) clearance under submission number K843062, sponsored by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-04-03.
- Submission: K843062
- Applicant / Sponsor: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 1985-04-03
Classification & Regulation
This clearance is catalogued under FDA product code LIZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.