The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Cholesterol Profile Kit.
| Device ID | K000603 |
| 510k Number | K000603 |
| Device Name: | SPIFE CHOLESTEROL PROFILE KIT |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Eric Petersen |
| Correspondent | Eric Petersen 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 | 2000-02-23 |
| Decision Date | 2000-04-17 |