K875311 is an FDA 510(k) clearance for the WELLCOZYME HSV WZO2. This device is classified as a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQN).
Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on August 3, 1988, 218 days after receiving the submission on December 29, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K875311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1987 |
| Decision Date | August 03, 1988 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQN — Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |