Clearance Summary
EXTENDSURE HBFASC CONTROL received FDA 510(k) clearance under submission number K053031, sponsored by Cantebury Scientific , 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 2005-12-07.
- Submission: K053031
- Applicant / Sponsor: Cantebury Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7415
- Decision date: 2005-12-07
Classification & Regulation
This clearance is catalogued under FDA product code JCM and 21 CFR 864.7415, within the Hematology review panel as a Class II device.