Clearance Summary
HEMOGLOBIN A1C CONTROL received FDA 510(k) clearance under submission number K021484, sponsored by Canterbury 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 2002-06-14.
- Submission: K021484
- Applicant / Sponsor: Canterbury Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2002-06-14
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.