The following data is part of a premarket notification filed by Sebia with the FDA for Hydragel Iso-pal K20 (pn 3022); Hydragel 7 Iso-pal (pn 4112); Hydragel 15 Iso-pal (pn 4132).
| Device ID | K011113 |
| 510k Number | K011113 |
| Device Name: | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-11 |
| Decision Date | 2001-06-13 |