The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Direct-sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit.
| Device ID | K935162 |
| 510k Number | K935162 |
| Device Name: | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE 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 | 1993-10-29 |
| Decision Date | 1994-11-10 |