The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Lipporotein-12, Model 3344.
| Device ID | K022333 |
| 510k Number | K022333 |
| Device Name: | SPIFE LIPPOROTEIN-12, MODEL 3344 |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia 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 | 2002-07-18 |
| Decision Date | 2002-08-15 |