The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Leap Mono Test Kit.
| Device ID | K840822 |
| 510k Number | K840822 |
| Device Name: | LEAP MONO TEST KIT |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | COOPER BIOMEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-04-05 |