The following data is part of a premarket notification filed by Fairleigh Dickinson Laboratories, Inc. with the FDA for Direct Elisa For Herpes Simplex Virus.
| Device ID | K853307 |
| 510k Number | K853307 |
| Device Name: | DIRECT ELISA FOR HERPES SIMPLEX VIRUS |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Contact | Terry L Foster |
| Correspondent | Terry L Foster FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-07 |
| Decision Date | 1985-12-23 |