The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Ebv-m Kit.
| Device ID | K822985 |
| 510k Number | K822985 |
| Device Name: | EBV-M KIT |
| Classification | Antiserum, Fluorescent, Epstein-barr Virus |
| Applicant | LITTON BIONETICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JRY |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-12 |
| Decision Date | 1982-12-03 |