The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Mono-plus(tm).
| Device ID | K883004 |
| 510k Number | K883004 |
| Device Name: | MONO-PLUS(TM) |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Contact | Ann Maclearie |
| Correspondent | Ann Maclearie WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-18 |
| Decision Date | 1988-08-04 |