The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel Ife Trivalent Antiserum.
| Device ID | K891188 |
| 510k Number | K891188 |
| Device Name: | TITAN GEL IFE TRIVALENT ANTISERUM |
| Classification | Radioimmunoassay, Immunoglobulins (g, A, M) |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Frank |
| Correspondent | Pat Frank HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | CFQ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-03-22 |