K810043 is an FDA 510(k) clearance for the GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I. This device is classified as a Antisera, Neutralization, Herpesvirus Hominis (Class II - Special Controls, product code GQM).
Submitted by Vibac Corp. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981, 128 days after receiving the submission on January 7, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K810043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1981 |
| Decision Date | May 15, 1981 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQM — Antisera, Neutralization, Herpesvirus Hominis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |