The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Herpes Virus Hominis Antibody Test Sys..
| Device ID | K812085 |
| 510k Number | K812085 |
| Device Name: | HERPES VIRUS HOMINIS ANTIBODY TEST SYS. |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | ZEUS SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-22 |
| Decision Date | 1981-09-01 |