DEN240035
- 510(k) number
- DEN240035
- Device name
- ConcizuTrace ELISA
- Applicant
- Randox Laboratories, Ltd. GB
- Product code
- SES — Non-Factor Replacement Product Test System
- Decision date
- 2025-05-22
- Date received
- 2024-07-01
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Hematology
Official FDA record: DEN240035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.