The following data is part of a premarket notification filed by Sebia with the FDA for Normal And Hypergamma Control Serum.
| Device ID | K040925 |
| 510k Number | K040925 |
| Device Name: | NORMAL AND HYPERGAMMA CONTROL SERUM |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-04-28 |