The following data is part of a premarket notification filed by Morax with the FDA for Hydragel If, 6 If, 12 If Penta Kits/hydragel If, Double If, 2 If, & 4 If Kits.
| Device ID | K960669 |
| 510k Number | K960669 |
| Device Name: | HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik 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 | 1996-02-20 |
| Decision Date | 1996-07-12 |