FDA Product Code PRD:
Leading manufacturers include Biofire Defense, LLC.
FDA 510(k) Cleared PRD Devices (Product Code PRD)
About Product Code PRD - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PRD since 2017, with 2 receiving FDA clearance (average review time: 100 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PRD submissions have been consistent, averaging 90 days recently vs 105 days historically.
PRD devices are reviewed by the Microbiology panel. Browse all Microbiology devices →