FDA Product Code CDD: Radioassay, Vitamin B12
Leading manufacturers include Beckman Coulter, Inc. and Axis-Shield Diagnostics, Ltd..
2
Total
2
Cleared
165d
Avg days
2022
Since
List of Radioassay, Vitamin B12 devices cleared through 510(k)
2 devices
Cleared
Jul 31, 2024
ARCHITECT Active-B12 (Holotranscobalamin)
Axis-Shield Diagnostics, Ltd.
Chemistry
271d
Cleared
Dec 23, 2022
Access Vitamin B12
Beckman Coulter, Inc.
Chemistry
59d
How to use this database
This page lists all FDA 510(k) submissions for Radioassay, Vitamin B12 devices (product code CDD). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →