The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Spe Plus-8 (ponceau S) 3165, Plus-8 No. 3175.
| Device ID | K900251 |
| 510k Number | K900251 |
| Device Name: | REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 |
| Classification | Electrophoretic, Protein Fractionation |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | CEF |
| CFR Regulation Number | 862.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-02-26 |