Clearance Summary
ARCHITECT Active-B12 (Holotranscobalamin) received FDA 510(k) clearance under submission number K233541, 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 2024-07-31.
- Submission: K233541
- 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: 2024-07-31
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.