Clearance Summary
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS received FDA 510(k) clearance under submission number K970836, sponsored by Becton Dickinson Immunocytometry Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-08-26.
- Submission: K970836
- Applicant / Sponsor: Becton Dickinson Immunocytometry Systems
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 1997-08-26
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.