The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Cmv-iha.
| Device ID | K852494 |
| 510k Number | K852494 |
| Device Name: | CMV-IHA |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Fuller |
| Correspondent | Fuller HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1985-09-16 |