The following data is part of a premarket notification filed by Morax with the FDA for Hydragel Ldl/hdl Chol Direct Kit-p.n. 4005, Hydragel 7 Ldl/hdl Chol Direct Kit-p.n. 4103, Hydragel Ldl/hdl Chol Direct 0.
| Device ID | K990250 |
| 510k Number | K990250 |
| Device Name: | HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 |
| 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 |
| Subsequent Product Code | JHO |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-26 |
| Decision Date | 1999-06-18 |