The following data is part of a premarket notification filed by Morax with the FDA for Hydragel 6 Csf Kit.
| Device ID | K981048 |
| 510k Number | K981048 |
| Device Name: | HYDRAGEL 6 CSF KIT |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik, Ph.d. |
| Correspondent | Borek Janik, Ph.d. MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Product Code | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-20 |
| Decision Date | 1998-10-07 |