ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)— 510(k) K160757

Substantially Equivalent

Axis-Shield Diagnostics Limited

FDA 510(k) clearance K160757 for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM), Substantially Equivalent on 2016-07-26. Applicant: Axis-Shield Diagnostics Limited.

Clearance details

Applicant: Axis-Shield Diagnostics Limited
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 2016-03-18
Decision date: 2016-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.