The following data is part of a premarket notification filed by Morax with the FDA for Hydragel-mini Iso-ck Kit, Hydragel Iso-ck Kit, Hydragel 7 Is0-ck Kit, Hydragel Iso-ck 15/30 Kit.
| Device ID | K992148 |
| 510k Number | K992148 |
| Device Name: | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-24 |
| Decision Date | 1999-12-29 |