The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Immunofix.
| Device ID | K923658 |
| 510k Number | K923658 |
| Device Name: | REP IMMUNOFIX |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| 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 | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-23 |
| Decision Date | 1992-11-02 |