The following data is part of a premarket notification filed by Sebia with the FDA for Hydragel Protein(e) Kit.
| Device ID | K951536 |
| 510k Number | K951536 |
| Device Name: | HYDRAGEL PROTEIN(E) KIT |
| Classification | Electrophoretic, Protein Fractionation |
| Applicant | SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Product Code | CEF |
| CFR Regulation Number | 862.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-06-30 |