The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Herpesvirus Hominis.
| Device ID | K791058 |
| 510k Number | K791058 |
| Device Name: | ANTIBODY TO HERPESVIRUS HOMINIS |
| Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-08 |
| Decision Date | 1979-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G5229026011 | K791058 | 000 |
| G522902600 | K791058 | 000 |
| G5229025011 | K791058 | 000 |
| G5229025001 | K791058 | 000 |