The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Oxoid Infectious Mononucleosis Kit.
| Device ID | K883540 |
| 510k Number | K883540 |
| Device Name: | OXOID INFECTIOUS MONONUCLEOSIS KIT |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | Mr. G Zajicek |
| Correspondent | Mr. G Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-18 |
| Decision Date | 1988-10-19 |