The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Im-check.
| Device ID | K834345 |
| 510k Number | K834345 |
| Device Name: | IM-CHECK |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | DIAGNOSTIC TECHNOLOGY, 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 | 1983-12-12 |
| Decision Date | 1984-02-10 |