The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Test Kit For Herpes Simplex Virus.
| Device ID | K792559 |
| 510k Number | K792559 |
| Device Name: | FIAX TEST KIT FOR HERPES SIMPLEX VIRUS |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-11 |
| Decision Date | 1980-03-03 |