The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife 2000/3000 Lipoprotein; Model# 3340, 3341, 3342, 3343.
| Device ID | K013466 |
| 510k Number | K013466 |
| Device Name: | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia 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 | 2001-10-18 |
| Decision Date | 2001-12-21 |