The following data is part of a premarket notification filed by Morax with the FDA for Hydragel Csf Isofocusing Kits.
| Device ID | K033277 |
| 510k Number | K033277 |
| Device Name: | HYDRAGEL CSF ISOFOCUSING KITS |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | MORAX SUITE 400 1705 CORPORATE DRIVE Norcross, GA 30093 |
| Contact | Borek Janik |
| Correspondent | Borek Janik MORAX SUITE 400 1705 CORPORATE DRIVE Norcross, GA 30093 |
| Product Code | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-10 |
| Decision Date | 2003-11-04 |
| Summary: | summary |