The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Modification Of Mono-plus(tm).
| Device ID | K883709 |
| 510k Number | K883709 |
| Device Name: | MODIFICATION OF MONO-PLUS(TM) |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Ann Maclearie |
| Correspondent | Ann Maclearie ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 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 | 1988-08-30 |
| Decision Date | 1988-12-20 |