Clearance Summary
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C received FDA 510(k) clearance under submission number K121842, sponsored by Axis-Shield Diagnostics, 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 2012-12-12.
- Submission: K121842
- Applicant / Sponsor: Axis-Shield Diagnostics, Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2012-12-12
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.