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 |