The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Mono-cube(tm).
| Device ID | K890991 |
| 510k Number | K890991 |
| Device Name: | MONO-CUBE(TM) |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | M. T Robert |
| Correspondent | M. T Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-03-16 |