The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Ebna Acif Kit.
| Device ID | K840417 |
| 510k Number | K840417 |
| Device Name: | EBNA ACIF KIT |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | LITTON BIONETICS 2020 BRIDGE VIEW DRIVE Charleston , SC 29405 - |
| Contact | Dale Kirkbride |
| Correspondent | Dale Kirkbride LITTON BIONETICS 2020 BRIDGE VIEW DRIVE Charleston , SC 29405 - |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-31 |
| Decision Date | 1984-12-27 |