The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Virgo Hsv-2 Igg Elisa.
| Device ID | K883281 |
| 510k Number | K883281 |
| Device Name: | VIRGO HSV-2 IGG ELISA |
| Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
| Applicant | ELECTRO-NUCLEONICS, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 -1297 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy ELECTRO-NUCLEONICS, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 -1297 |
| Product Code | GQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-03 |
| Decision Date | 1989-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747042 | K883281 | 000 |
| 05391516743495 | K883281 | 000 |