Clearance Summary
PROFILE 750 BLOOD CELL COUNTER received FDA 510(k) clearance under submission number K823886, sponsored by Mallinckrodt Critical Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-03-01.
- Submission: K823886
- Applicant / Sponsor: Mallinckrodt Critical Care
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5200
- Decision date: 1983-03-01
Classification & Regulation
This clearance is catalogued under FDA product code GKL and 21 CFR 864.5200, within the Hematology review panel as a Class II device.