The following data is part of a premarket notification filed by Val Tech Diagnostics, Inc. with the FDA for Herpes Virus Control Slides.
| Device ID | K883684 |
| 510k Number | K883684 |
| Device Name: | HERPES VIRUS CONTROL SLIDES |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh, PA 15215 |
| Contact | Steve L Sinka |
| Correspondent | Steve L Sinka VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh, PA 15215 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-29 |
| Decision Date | 1988-09-28 |