The following data is part of a premarket notification filed by Sebia with the FDA for Gelscan, Model 1206.
| Device ID | K100307 |
| 510k Number | K100307 |
| Device Name: | GELSCAN, MODEL 1206 |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Applicant | SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Product Code | CFE |
| Subsequent Product Code | CIN |
| Subsequent Product Code | JHY |
| Subsequent Product Code | JQT |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-03 |
| Decision Date | 2010-08-31 |