FDA Product Code LEH: Radioimmunoassay, Vancomycin
Leading manufacturers include Siemens Healthcare Diagnostics, Inc..
31
Total
31
Cleared
88d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Radioimmunoassay, Vancomycin Devices (Product Code LEH)
31 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
About Product Code LEH - Regulatory Context
510(k) Submission Activity
31 total 510(k) submissions under product code LEH since 1981, with 31 receiving FDA clearance (average review time: 88 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LEH devices are reviewed by the Toxicology panel. Browse all Toxicology devices →