The following data is part of a premarket notification filed by Tago, Inc. with the FDA for Diffu-gen Apolipoprotein A-i Radial -.
| Device ID | K834218 |
| 510k Number | K834218 |
| Device Name: | DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - |
| Classification | Apolipoproteins |
| Applicant | TAGO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-05-11 |