K830953 is an FDA 510(k) clearance for the MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION. This device is classified as a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQL).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983, 89 days after receiving the submission on March 25, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K830953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1983 |
| Decision Date | June 22, 1983 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |