The following data is part of a premarket notification filed by Sebia with the FDA for Hyragel Iso-ldh Kit/hydragel 15 Iso-ldh Kit.
| Device ID | K970477 |
| 510k Number | K970477 |
| Device Name: | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Applicant | SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Contact | Borek Janik, Ph.d. |
| Correspondent | Borek Janik, Ph.d. SEBIA 13805 WATERLOO Chelsea, MI 48118 |
| Product Code | CFE |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-07 |
| Decision Date | 1997-03-10 |