The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Monosticon Uni-dot.
| Device ID | K853388 |
| 510k Number | K853388 |
| Device Name: | MONOSTICON UNI-DOT |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | ORGANON, INC. West Orange, NJ 07052 |
| Contact | Patrick J Osinski |
| Correspondent | Patrick J Osinski ORGANON, INC. West Orange, NJ 07052 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-13 |
| Decision Date | 1985-08-22 |