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..
List of Non-factor Replacement Product Test System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Non-factor Replacement Product Test System devices (product code SES). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Hematology FDA review panel. Browse all Hematology devices →