The following data is part of a premarket notification filed by Tago, Inc. with the FDA for Tago Diffu-gen-apolipoprotein B-100.
| Device ID | K833129 |
| 510k Number | K833129 |
| Device Name: | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 |
| Classification | Apolipoproteins |
| Applicant | TAGO, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-13 |
| Decision Date | 1983-11-21 |