K203184 is an FDA 510(k) clearance for the HYDRASHIFT 2/4 isatuximab. This device is classified as a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II - Special Controls, product code CFF).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on November 12, 2021, 381 days after receiving the submission on October 27, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K203184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2020 |
| Decision Date | November 12, 2021 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |