The following data is part of a premarket notification filed by Tago, Inc. with the FDA for Tago Fiffu-gen, Orosomucoid.
| Device ID | K841734 |
| 510k Number | K841734 |
| Device Name: | TAGO FIFFU-GEN, OROSOMUCOID |
| Classification | Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Applicant | TAGO, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | LKL |
| CFR Regulation Number | 866.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-26 |
| Decision Date | 1984-06-01 |