FDA Product Code JSM: Culture Media, Non-propagating Transport
Leading manufacturers include Copan Italia Spa, Arx Sciences, Inc. and Alb Luz.
FDA 510(k) Cleared Culture Media, Non-propagating Transport Devices (Product Code JSM)
About Product Code JSM - Regulatory Context
510(k) Submission Activity
111 total 510(k) submissions under product code JSM since 1979, with 111 receiving FDA clearance (average review time: 136 days).
Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 11 in the prior period.
FDA Review Time
Recent submissions under JSM have taken an average of 366 days to reach a decision - up from 118 days historically. Manufacturers should account for longer review timelines in current project planning.
JSM devices are reviewed by the Microbiology panel. Browse all Microbiology devices →