The following data is part of a premarket notification filed by Tago, Inc. with the FDA for Mono Screening Test.
| Device ID | K830531 |
| 510k Number | K830531 |
| Device Name: | MONO SCREENING TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | TAGO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-18 |
| Decision Date | 1983-03-17 |