The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife 2000/3000 Alp 40, 20; Models 3345 And 3346.
| Device ID | K020625 |
| 510k Number | K020625 |
| Device Name: | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 |
| Classification | Electrophoretic Separation, Alkaline Phosphatase 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 | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-26 |
| Decision Date | 2002-05-06 |