The following data is part of a premarket notification filed by Genbio with the FDA for Immunodot Mono-m Test.
| Device ID | K974244 |
| 510k Number | K974244 |
| Device Name: | IMMUNODOT MONO-M TEST |
| Classification | Epstein-barr Virus, Other |
| Applicant | GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
| Contact | Bryan Kiehl |
| Correspondent | Bryan Kiehl GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-09-22 |
| Summary: | summary |