K853307 is an FDA 510(k) clearance for the DIRECT ELISA FOR HERPES SIMPLEX VIRUS. This device is classified as a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQN).
Submitted by Fairleigh Dickinson Laboratories, Inc. (Abilene, US). The FDA issued a Cleared decision on December 23, 1985, 138 days after receiving the submission on August 7, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K853307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1985 |
| Decision Date | December 23, 1985 |
| Days to Decision | 138 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 |