The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep 3 Flur Spe-60 Kit.
| Device ID | K964453 |
| 510k Number | K964453 |
| Device Name: | REP 3 FLUR SPE-60 KIT |
| 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 | 1996-11-06 |
| Decision Date | 1996-12-23 |