JXO · Class II · 21 CFR 862.3250

FDA Product Code JXO: Enzyme Immunoassay, Cocaine

Leading manufacturers include Psychemedics Corporation.

6
Total
6
Cleared
185d
Avg days
1991
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Enzyme Immunoassay, Cocaine Devices (Product Code JXO)

6 devices
1–6 of 6

About Product Code JXO - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code JXO since 1991, with 6 receiving FDA clearance (average review time: 185 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

JXO devices are reviewed by the Toxicology panel. Browse all Toxicology devices →