JMG · Class II · 21 CFR 866.5340

FDA Product Code JMG: Radioimmunoassay (two-site Solid Phase), Ferritin

Leading manufacturers include Beckman Coulter, Inc..

24
Total
24
Cleared
64d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Radioimmunoassay (two-site Solid Phase), Ferritin Devices (Product Code JMG)

24 devices
1–24 of 24

About Product Code JMG - Regulatory Context

510(k) Submission Activity

24 total 510(k) submissions under product code JMG since 1978, with 24 receiving FDA clearance (average review time: 64 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

JMG devices are reviewed by the Immunology panel. Browse all Immunology devices →