The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Dryspot Infectious Mononucleosis Kit.
| Device ID | K982634 |
| 510k Number | K982634 |
| Device Name: | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Contact | Andy Hollingsworth |
| Correspondent | Andy Hollingsworth OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-28 |
| Decision Date | 1999-01-28 |