510(k) DEN240035
DEN240035 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "ConcizuTrace ELISA". The FDA issued a decision of De Novo Granted on May 22, 2025. The device falls under product code SES (Non-Factor Replacement Product Test System), a Class II device regulated under 21 CFR 864.7298. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 22, 2025
- Date Received
- July 1, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Factor Replacement Product Test System
- Device Class
- Class II
- Regulation Number
- 864.7298
- Review Panel
- HE
- Submission Type
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.