510(k) DEN240035
- Device
- ConcizuTrace™ ELISA
- Applicant
- Randox Laboratories, Ltd.
- 510(k) number
- DEN240035
- Product code
- SES
- Decision
- Unknown (DENG)
- Decision date
- 2025-05-22
- Date received
- 2024-07-01
- Regulation
- 864.7298
- Classification name
- Non-Factor Replacement Product Test System
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Karena Shaw
- Address
- 55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY
FDA Registration Numbers#
- 3004493545
- 3014607865
Source Documents#
510(k) summary PDF not indicated by FDA