The following data is part of a premarket notification filed by Akers Research Corp. with the FDA for Healthtest Infectious Mononucleosis Assay.
| Device ID | K920221 |
| 510k Number | K920221 |
| Device Name: | HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | AKERS RESEARCH CORP. 201 GROVE ROAD, SUITE #1 Thorofare, NJ 08086 |
| Contact | Akers, Jr. |
| Correspondent | Akers, Jr. AKERS RESEARCH CORP. 201 GROVE ROAD, SUITE #1 Thorofare, NJ 08086 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-16 |
| Decision Date | 1992-03-13 |