The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Ebna Antibody Test System (immunoenzyme Antibody).
| Device ID | K895707 |
| 510k Number | K895707 |
| Device Name: | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Contact | Don W Valencia |
| Correspondent | Don W Valencia IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-12-08 |