FDA Product Code
FDA Product Code SES — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7298
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN240035 | ConcizuTrace ELISA | Randox Laboratories, Ltd. | 2025-05-22 | Direct | — |
Product code SES · Class II · Hematology. Data: openFDA.