Clearance Summary
EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS received FDA 510(k) clearance under submission number K071648, sponsored by Canterbury Scientific , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2007-08-22.
- Submission: K071648
- Applicant / Sponsor: Canterbury Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2007-08-22
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.