K791397 is an FDA 510(k) clearance for the HERPES EIA TEST KIT. This device is classified as a Antisera, Neutralization, Herpesvirus Hominis (Class II - Special Controls, product code GQM).
Submitted by Microbiological Assoc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979, 59 days after receiving the submission on July 27, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K791397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1979 |
| Decision Date | September 24, 1979 |
| Days to Decision | 59 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 |