FDA Product Code DLZ: Enzyme Immunoassay, Phenobarbital
Leading manufacturers include Ortho-Clinical Diagnostics, Inc..
35
Total
35
Cleared
76d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Enzyme Immunoassay, Phenobarbital Devices (Product Code DLZ)
35 devices
About Product Code DLZ - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code DLZ since 1977, with 35 receiving FDA clearance (average review time: 76 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
DLZ devices are reviewed by the Toxicology panel. Browse all Toxicology devices →