The following data is part of a premarket notification filed by Microbiological Assoc. with the FDA for Herpes Eia Test Kit.
| Device ID | K791397 |
| 510k Number | K791397 |
| Device Name: | HERPES EIA TEST KIT |
| Classification | Antisera, Neutralization, Herpesvirus Hominis |
| Applicant | MICROBIOLOGICAL ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQM |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-27 |
| Decision Date | 1979-09-24 |