The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Ultra Hdl,vldl/ldl Cholesterol System.
| Device ID | K904035 |
| 510k Number | K904035 |
| Device Name: | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM |
| Classification | Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | LBT |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-31 |
| Decision Date | 1990-11-09 |