The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Herpes Simplex Group Cf Antigen.
| Device ID | K850609 |
| 510k Number | K850609 |
| Device Name: | HERPES SIMPLEX GROUP CF ANTIGEN |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Louis C Cullman |
| Correspondent | Louis C Cullman HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-15 |
| Decision Date | 1985-05-09 |