The following data is part of a premarket notification filed by Morax with the FDA for Hydragel 7,15,30, Chol-hdl Kit.
| Device ID | K972015 |
| 510k Number | K972015 |
| Device Name: | HYDRAGEL 7,15,30, CHOL-HDL KIT |
| Classification | Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Product Code | LBT |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-10-27 |