The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Ebv Early Antigen (r+d).
| Device ID | K884829 |
| 510k Number | K884829 |
| Device Name: | EBV EARLY ANTIGEN (R+D) |
| Classification | Antiserum, Fluorescent, Epstein-barr Virus |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Carolyn B Wagner |
| Correspondent | Carolyn B Wagner HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | JRY |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1989-04-12 |