The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcozyme Hsv Wzo2.
| Device ID | K875311 |
| 510k Number | K875311 |
| Device Name: | WELLCOZYME HSV WZO2 |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Moody, Phd |
| Correspondent | Moody, Phd WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-08-03 |