The following data is part of a premarket notification filed by Organon Teknika Treyburn with the FDA for Ebv-ea Ifa Kit.
| Device ID | K895652 |
| 510k Number | K895652 |
| Device Name: | EBV-EA IFA KIT |
| Classification | Epstein-barr Virus, Other |
| Applicant | ORGANON TEKNIKA TREYBURN 100 AKZO AVE. Durham, NC 27704 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn ORGANON TEKNIKA TREYBURN 100 AKZO AVE. Durham, NC 27704 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-12-18 |