FDA Product Code LEH: Radioimmunoassay, Vancomycin
Leading manufacturers include Siemens Healthcare Diagnostics, Inc..
2
Total
2
Cleared
226d
Avg days
2016
Since
List of Radioimmunoassay, Vancomycin devices cleared through 510(k)
2 devices
Cleared
Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics, Inc.
Toxicology
361d
Cleared
Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
Siemens Healthcare Diagnostics, Inc.
Toxicology
90d
How to use this database
This page lists all FDA 510(k) submissions for Radioimmunoassay, Vancomycin devices (product code LEH). 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 Toxicology FDA review panel. Browse all Toxicology devices →