The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Ebna Antibody.
| Device ID | K875170 |
| 510k Number | K875170 |
| Device Name: | EBNA ANTIBODY |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Moore, Phd |
| Correspondent | Moore, Phd HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-05-23 |