Clearance Summary
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) received FDA 510(k) clearance under submission number K160757, sponsored by Axis-Shield Diagnostics Limited. 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 2016-07-26.
- Submission: K160757
- Applicant / Sponsor: Axis-Shield Diagnostics Limited
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 2016-07-26
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.