The following data is part of a premarket notification filed by Tago, Inc. with the FDA for Diffu-gen Haptoglobin Radial Immuno.
| Device ID | K840404 |
| 510k Number | K840404 |
| Device Name: | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO |
| Classification | Haptoglobin, Antigen, Antiserum, Control |
| Applicant | TAGO, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | DAD |
| CFR Regulation Number | 866.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-31 |
| Decision Date | 1984-03-09 |