Panels › Hematology › Product code SES · Class 2
Non-Factor Replacement Product Test System
Regulation 864.7298
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SES
| Company | 510(k)s | Recalls |
|---|---|---|
| Randox Laboratories, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 2025 | DEN240035 | ConcizuTrace ELISA Randox Laboratories, Ltd., GB | SES |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.