FDA Product Code SES: Non-factor Replacement Product Test System
A Non-factor Replacement Product Test System Is A Prescription In Vitro Diagnostic Device Intended To Measure Non-factor Replacement Therapeutic Products That Are Indicated For Routine Prophylaxis To Prevent Or Reduce The Frequency Of Bleeding Episodes In Patients With Bleeding Disorders, Including Hemophilia, In Human Blood Specimens To Ensure Appropriate Therapy In Accordance With The Approved Non-factor Replacement Product Labeling.
Leading manufacturers include Randox Laboratories, Ltd..
FDA 510(k) Cleared Non-factor Replacement Product Test System Devices (Product Code SES)
About Product Code SES - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SES since 2025, with 0 receiving FDA clearance (average review time: 325 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.
SES devices are reviewed by the Hematology panel. Browse all Hematology devices →