Clearance Summary
CELL-DYN CALIBRATOR received FDA 510(k) clearance under submission number K902892, sponsored by Unipath , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1990-09-10.
- Submission: K902892
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8165
- Decision date: 1990-09-10
Classification & Regulation
This clearance is catalogued under FDA product code KRZ and 21 CFR 864.8165, within the Hematology review panel as a Class II device.