The following data is part of a premarket notification filed by American Dade with the FDA for Series I/s Infections.
| Device ID | K844289 |
| 510k Number | K844289 |
| Device Name: | SERIES I/S INFECTIONS |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | James E Keller |
| Correspondent | James E Keller AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-05 |
| Decision Date | 1984-11-19 |