The following data is part of a premarket notification filed by Tago, Inc. with the FDA for Tago Diffu-gen C-reactive Protein.
| Device ID | K841265 |
| 510k Number | K841265 |
| Device Name: | TAGO DIFFU-GEN C-REACTIVE PROTEIN |
| Classification | System, Test, C-reactive Protein |
| Applicant | TAGO, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-26 |
| Decision Date | 1984-05-22 |