The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Ld-12 Kit, Model 3338.
| Device ID | K022455 |
| 510k Number | K022455 |
| Device Name: | SPIFE LD-12 KIT, MODEL 3338 |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| 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 | CFE |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-26 |
| Decision Date | 2002-10-01 |