Clearance Summary
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) received FDA 510(k) clearance under submission number K112443, sponsored by Axis-Shield Diagnostics, 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 2011-12-19.
- Submission: K112443
- Applicant / Sponsor: Axis-Shield Diagnostics, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 2011-12-19
Classification & Regulation
This clearance is catalogued under FDA product code CDD and 21 CFR 862.1810, within the Clinical Chemistry review panel as a Class II device.