The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Herpes Ident. & Typing Test Hitt.
| Device ID | K831504 |
| 510k Number | K831504 |
| Device Name: | HERPES IDENT. & TYPING TEST HITT |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, 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 | 1983-05-11 |
| Decision Date | 1983-09-20 |