The following data is part of a premarket notification filed by Morax with the FDA for Hydragel 15 Hb A1c Kit.
| Device ID | K963844 |
| 510k Number | K963844 |
| Device Name: | HYDRAGEL 15 HB A1C KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1997-04-22 |