The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Cholesterol Profile Kit.
| Device ID | K992971 |
| 510k Number | K992971 |
| Device Name: | REP CHOLESTEROL PROFILE KIT |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Eric Peterson |
| Correspondent | Eric Peterson HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 1999-10-18 |