The following data is part of a premarket notification filed by Sebia with the FDA for Hydrashift 2/4 Isatuximab.
| Device ID | K203184 |
| 510k Number | K203184 |
| Device Name: | HYDRASHIFT 2/4 Isatuximab |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30096 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30096 |
| Product Code | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-27 |
| Decision Date | 2021-11-12 |