The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Immunocard Mono.
| Device ID | K930778 |
| 510k Number | K930778 |
| Device Name: | IMMUNOCARD MONO |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen Nickol |
| Correspondent | Allen Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-16 |
| Decision Date | 1993-12-27 |