The following data is part of a premarket notification filed by Morax with the FDA for Hydragel Bence Jones Kit/maxi Kit Hydragel Bence Jones/hydragel 2/4 Bence Jones Kit.
| Device ID | K972591 |
| 510k Number | K972591 |
| Device Name: | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT |
| Classification | Immunochemical, Bence-jones Protein |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Product Code | JKM |
| CFR Regulation Number | 866.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1998-03-04 |