The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep 3 Quto-flur Cholesterol-30.
| Device ID | K962914 |
| 510k Number | K962914 |
| Device Name: | REP 3 QUTO-FLUR CHOLESTEROL-30 |
| Classification | Electrophoretic Separation, Lipoproteins |
| 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 | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-26 |
| Decision Date | 1997-01-13 |