The following data is part of a premarket notification filed by Genus Diagnostics with the FDA for Hsv Idr.
| Device ID | K854974 |
| 510k Number | K854974 |
| Device Name: | HSV IDR |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
| Contact | Mark P Bear |
| Correspondent | Mark P Bear GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-03-07 |