ConcizuTrace™ ELISA
FDA 510(k) clearance DEN240035 · decided 2025-05-22
Clearance details
- K-number
- DEN240035
- Device name
- ConcizuTrace™ ELISA
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Unknown
- Date received
- 2024-07-01
- Decision date
- 2025-05-22
- Days to decision
- 325 days
- Clearance type
- Direct
- Product code
- SES
- Device class
- 2
- Regulation number
- 864.7298
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Crumlin, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.