FDA Product Code CGN: Acid, Folic, Radioimmunoassay
Leading manufacturers include Beckman Coulter, Inc. and Roche Diagnostics.
2
Total
2
Cleared
266d
Avg days
2023
Since
List of Acid, Folic, Radioimmunoassay devices cleared through 510(k)
2 devices
Cleared
Jun 17, 2024
Elecsys Folate III
Roche Diagnostics
Chemistry
266d
Cleared
Aug 23, 2023
Access Folate Assay
Beckman Coulter, Inc.
Chemistry
265d
How to use this database
This page lists all FDA 510(k) submissions for Acid, Folic, Radioimmunoassay devices (product code CGN). 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 →