The following data is part of a premarket notification filed by Morax with the FDA for Hydragel 7,15,30, Chol-hdl Kit.
Device ID | K972015 |
510k Number | K972015 |
Device Name: | HYDRAGEL 7,15,30, CHOL-HDL KIT |
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 |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-30 |
Decision Date | 1997-10-27 |