The following data is part of a premarket notification filed by Morax with the FDA for Hydragel Hemoglobin(e), Mini Hemoglobin(e), 7 Hemoglobin(e), 15 Hemoglobin(e), Acid(e) Hemoglobin(e), Mini Acid(e) Hemo).
| Device ID | K991362 |
| 510k Number | K991362 |
| Device Name: | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) |
| Classification | System, Analysis, Electrophoretic Hemoglobin |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Product Code | JBD |
| Subsequent Product Code | GIQ |
| Subsequent Product Code | GKA |
| Subsequent Product Code | KQI |
| Subsequent Product Code | MLL |
| CFR Regulation Number | 864.7440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-14 |
| Decision Date | 1999-06-21 |