The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife 3000 Titan Gel Igg Ief Kit, Model 3389.
| Device ID | K024162 |
| 510k Number | K024162 |
| Device Name: | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| 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 | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-17 |
| Decision Date | 2003-02-19 |