SES — Non-Factor Replacement Product Test System Class II
FDA product code SES covers "Non-Factor Replacement Product Test System", a Class II medical device regulated under 21 CFR 864.7298. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SES
- Device Class
- Class II
- Regulation Number
- 864.7298
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240035 | randox laboratories | ConcizuTrace ELISA | May 22, 2025 |